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

Catalog Number 6393190

Device Problems Loss of or Failure to Bond (1068); Material Separation (1562); Separation Failure (2547); Difficult or Delayed Separation (4044)

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

Event Date 01/04/2023

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 return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 09/2023).Device pending return.

Event Description

It was reported that the during a dialysis catheter placement procedure, the clear inner plastic on the peel-away sheath allegedly detached from the outer white plastic when the introducer is removed.There was no reported patient injury.

Event Description

It was reported that the during a dialysis catheter placement procedure, the clear inner plastic on the peel-away sheath allegedly detached from the outer white plastic when the introducer is removed.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 15.0 fully peeled peel-apart sheath was returned for evaluation.Gross visual evaluation was performed.One detached valve cap was returned with the sample and twists and bunching were noted throughout both peeled sheath shafts.Therefore the investigation is confirmed for the reported material separation and identified separation failure issue as the valve was noted to be detached.A definitive root cause could not be determined based upon the 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: 09/2023), g3, h6 (device).H11: h6 (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 the during a dialysis catheter placement procedure, the clear inner plastic on the peel-away sheath allegedly detached from the outer white plastic when the introducer is removed.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 15.0 fully peeled peel-apart sheath was returned for evaluation.Gross visual evaluation was performed.One detached valve cap was returned with the sample and twists and bunching were noted throughout both peeled sheath shafts.Manufacturing site evaluation of the sample found that one of the top cap halves was completely detached from the handle, the valve half in this same section was observed to be absent in the sample, slight adhesion marks of the detached top cap to the handle were observed.Therefore, the investigation is confirmed for the reported material separation, loss or failure to bond and identified delayed separation issues as the valve was noted to be detached.The root cause was determined to be manufacturing related.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: 09/2023).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.

• Brand Name: GLIDEPATH
• 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: 16270365
• MDR Text Key: 308836171
• Report Number: 3006260740-2023-00280
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741138492
• UDI-Public: (01)00801741138492
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6393190
• Device Lot Number: REFX5702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2021
• 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