MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HEMOSPLIT CATHETER; DIALYSIS CATHETER

Model Number 5733690

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2022

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation and photos were provided for review.The investigation of the reported event is currently underway.(expiration date: 01/2023).

Event Description

It was reported that prior to a catheter placement procedure, the packaging of the device allegedly found to have white powder inside the product packing and also inside the peal away sheath.It was further reported that the catheter tray was completely unsterile with dirty sticker.There was no patient involvement.

Event Description

It was reported that prior to a catheter placement procedure, the packaging of the device allegedly found to have white powder inside the product packing and also inside the peal away sheath.It was further reported that the catheter tray was completely unsterile with dirty sticker.There was no patient involvement.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one unsealed 19cmhemosplit d/l catheter kit and six electronic photos were provided for review.Gross visual evaluation was performed on the returned device kit.The investigation is confirmed for the reported contamination issue as white powder like substance was noted inside the packaging tray of the device.Further, the photo review also confirms the same.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiration date: 01/2023).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : see h10.

Event Description

It was reported that prior to a catheter placement procedure, the packaging of the device allegedly found to have white powder inside the product packing and also inside the peal away sheath.It was further reported that the catheter tray was completely unsterile with dirty sticker.There was no patient involvement.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one unsealed 19cmhemosplit d/l catheter kit and six electronic photos were provided for review.Gross visual evaluation was performed on the returned device kit.During visual evaluation, no signs of wear or any degradation was noted on all the silicone components within the kit.The metal component (tunneler) had no damage throughout.The investigation is confirmed for the reported contamination issue, as white powder like substance was noted inside the packaging tray of the device.Furthermore, ftir analysis was conducted on the foreign material consisting of fine particulates found inside the packaging (white powder) and introducer sheath (red tint).Both sets of particles were examined by sem/eds.Eds analysis of the crystalline structure was consistent with dried salt (na/cl).Eds analysis of the debris agglomerations showed significant silicon (si), carbon (c) and oxygen (o).Sem analysis of the introducer sheath particles showed a morphology consistent with the debris agglomerations from the packaging with the additional particles along the surface.Eds analysis of the particles showed a similar spectrum of si/c/o with minor amounts of aluminum (al), calcium (ca), iron (fe) and dried salt detected.The particles were examined by micro-atr ftir.Both sets of particles showed similar ftir spectrum which show good correlation to polydimethlysiloxane, which is a common silicone based polymeric material and corresponds to the eds findings.The morphology of the particles suggests they were the result of a mechanical action which resulted in debris formation.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiration date: 01/2023).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : see h10.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one unsealed 19cmhemosplit d/l catheter kit and six electronic photos were provided for review.Gross visual evaluation was performed on the returned device kit.During visual evaluation, no signs of wear or any degradation was noted on all the silicone components within the kit.The metal component (tunneler) had no damage throughout.The investigation is confirmed for the reported contamination issue, as white powder like substance was noted inside the packaging tray of the device.Furthermore, during the sample evaluation, two small holes were found on the bottom right corner of the top product label (tyvek label) were considered to be an incidental findings since it was not related to the original reported event.Manufacturing site evaluation found certain components within the kit that have some of the materials found in the debris within the kit.Not all components were returned, but no wear or any degradation was found on the silicone components and no damage was found on the metal tunneler.Therefore the contamination cannot be determined to be due to damage to the kit components.However, no solidification of the silicone lubricant has been observed or reported during the manufacturing process.In addition to this, the r&d team states that during the shipping process a white silicone lubricant may be applied to the tray as an antistatic and lubricant agent.However, no evidence has been found to suggest that this lubricant is the source of the silicone contamination observed.Furthermore, ftir analysis was conducted on the foreign material consisting of fine particulates found inside the packaging (white powder) and introducer sheath (red tint).Both sets of particles were examined by sem/eds.Eds analysis of the crystalline structure was consistent with dried salt (na/cl).Eds analysis of the debris agglomerations showed significant silicon (si), carbon (c) and oxygen (o).Sem analysis of the introducer sheath particles showed a morphology consistent with the debris agglomerations from the packaging with the additional particles along the surface.Eds analysis of the particles showed a similar spectrum of si/c/o with minor amounts of aluminum (al), calcium (ca), iron (fe) and dried salt detected.The particles were examined by micro-atr ftir.Both sets of particles showed similar ftir spectrum which show good correlation to polydimethlysiloxane, which is a common silicone based polymeric material and corresponds to the eds findings.The morphology of the particles suggests they were the result of a mechanical action which resulted in debris formation.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiration date: 01/2023).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : see h10.

Event Description

It was reported that prior to a catheter placement procedure, the packaging of the device allegedly found to have white powder inside the product packing and also inside the peal away sheath.It was further reported that the catheter tray was completely unsterile with dirty sticker.There was no patient involvement.

• Brand Name: HEMOSPLIT CATHETER
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 14039716
• MDR Text Key: 288774914
• Report Number: 3006260740-2022-01162
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741013096
• UDI-Public: (01)00801741013096
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K030020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5733690
• Device Catalogue Number: 5733690
• Device Lot Number: REFP4505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1