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

Model Number 5833690

Device Problems Difficult to Insert (1316); Failure to Advance (2524); Material Deformation (2976); Material Twisted/Bent (2981); Packaging Problem (3007); Component Misassembled (4004)

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

Event Date 02/26/2023

Event Type  malfunction  

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 03/2024).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.

Event Description

It was reported that during a dialysis catheter placement procedure, catheter was allegedly twisted.It was further reported that catheter was allegedly difficult to pass over the guidewire.Reportedly, the catheter was removed and the procedure was completed using another device.There was no reported patient injury.

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 19cm hemostar d/l catheter kit.Following components were received: one 19cm hemostar d/l catheter, one 8fr dilator, one 12fr dilator, one 15fr peel-apart sheath and vessel dilator, one j-tip guidewire in a guidewire hoop, one tunneler, one introducer needle and two end caps were returned for evaluation.Gross visual, tactile and functional evaluations were performed.The 19cm hemostar d/l catheter was noted to be bent.In addition to the returned physical sample, four electronic photos were provided for review.The photo shows the catheter placed in a unsealed sample tray and the catheter was noted to be bent.Therefore the investigation is confirmed for the reported material twist/ bent issues.However the investigation is inconclusive for the reported failure to advance issue as the exact circumstances at the time of the reported event was unknown.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 (expiry date: 03/2024), g3 h11: h6 (device, method, result, conclusion) 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.

Event Description

It was reported that during a dialysis catheter placement procedure, catheter was allegedly twisted.It was further reported that catheter was allegedly difficult to pass over the guidewire.Reportedly, the catheter was removed and the procedure was completed using another device.There was no reported patient injury.

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 19cm hemostar d/l catheter kit.Various components were returned for evaluation, including the catheter.Gross visual, tactile and functional evaluations were performed.The 19cm hemostar d/l catheter was noted to be bent.In addition to the returned physical sample, four electronic photos were provided for review.These four electronic photos were reviewed.The photos show a 19cm hemostar d/l catheter.Photos depicting the catheter in the tray show it is curved and oriented in a manner similar to the specified packaging orientation of pre-curved catheters, although this is a straight catheter.That is, the catheter is doubled back on itself in a "u" shape, with the tip in a protective tube taped to the rigid packaging.No packaging damage was noted.It is unknown what "indentations" in the packaging may be referred to, and also the photographs do not constitute a complete unobstructed view of the tray and retainer components, and so the reported packaging/packaging deformation issues will remain inconclusive.The catheter bending can be confirmed based on the sample evaluation.Misassembly of the components is also confirmed.The difficulty of advancement cannot be confirmed from the available samples.The cause of this condition is related to incorrect packaging during manufacturing.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: b5, d4 (expiration date: 03/2024).H11: section a through f ¿ the information provided by bd represents all 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.

Event Description

It was reported that during a dialysis catheter placement procedure, catheter was allegedly twisted.It was further reported that catheter was allegedly difficult to pass over the guidewire.Furthermore, the outer packaging allegedly had severe plastic indentations and cannot be opened.Reportedly, the catheter was removed and the procedure was completed using another device.There was no reported patient injury.

• Brand Name: HEMOSTAR
• 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: 16893688
• MDR Text Key: 314800979
• Report Number: 3006260740-2023-01753
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741013386
• UDI-Public: (01)00801741013386
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K051748
• 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
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5833690
• Device Catalogue Number: 5833690
• Device Lot Number: REGU3313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2023
• Initial Date FDA Received: 05/09/2023
• Supplement Dates Manufacturer Received: 08/10/2023; 04/09/2024
• Supplement Dates FDA Received: 08/12/2023; 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2022
• 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