MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BROVIAC CV CATHETER REPAIR KIT, SINGLE-LUMEN,WHITE, 4.2F; PORT AND CATHETER ACCESSORIES

Model Number	0601610
Medical Device Problem Codes	Coagulation in Device or Device Ingredient (1096); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation of a catheter repairing procedure, the adhesive on the device was allegedly solid and wouldn't come out of tube.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
A voluntary recall has been initiated for catheter repair kits which are product catalog/lot number specific.Reportedly the catheter repair kits have hardened/coagulated adhesive.Hardened or coagulated adhesive has the potential to cause delays whilst an alternative repair kit, adhesive or replacement catheter is obtained; therefore, potentially prolonging surgery or necessitating exchange.To date there have been no adverse events worldwide reported related to this issue.As result of the field action, this event is being reported as a malfunction reportable event.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.Expiration date: 09/2023.Device pending return.
Additional Manufacturer Narrative
H10: a voluntary recall has been initiated for catheter repair kits which are product catalog/lot number specific.Reportedly the catheter repair kits have hardened/coagulated adhesive.Hardened or coagulated adhesive has the potential to cause delays whilst an alternative repair kit, adhesive or replacement catheter is obtained; therefore, potentially prolonging surgery or necessitating exchange.To date there have been no adverse events worldwide reported related to this issue.As result of the field action, this event is being reported as a malfunction reportable event.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: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.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: 09/2023).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.H3 other text : device not returned.
Event or Problem Description
It was reported that during preparation of a catheter repairing procedure, the adhesive on the device was allegedly solid and wouldn't come out of tube.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
H10: a voluntary recall has been initiated for catheter repair kits which are product catalog/lot number specific.Reportedly the catheter repair kits have hardened/coagulated adhesive.Hardened or coagulated adhesive has the potential to cause delays whilst an alternative repair kit, adhesive or replacement catheter is obtained; therefore, potentially prolonging surgery or necessitating exchange.To date there have been no adverse events worldwide reported related to this issue.As result of the field action, this event is being reported as a malfunction reportable event.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 silicone adhesive tube were returned for evaluation.Gross visual evaluations was performed.The investigation is confirmed for the reported coagulation in device, as the tube felt stiff, not spongy.However, the investigation is inconclusive for the reported non standard device issue, as the exact circumstances at the time of the reported event cannot be verified from the returned physical sample.A 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: 09/2023), g3, h2 h11: h6 (method, result) 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 or Problem Description
It was reported that during preparation of a catheter repairing procedure, the adhesive on the device was allegedly solid and wouldn't come out of tube.The procedure was completed using another device.There was no patient contact.

• Brand Name: BROVIAC CV CATHETER REPAIR KIT, SINGLE-LUMEN,WHITE, 4.2F
• Common Device Name: PORT AND CATHETER ACCESSORIES
• 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: 16385692
• Report Number: 3006260740-2023-00459
• Device Sequence Number: 14876513
• Product Code: LJS
• UDI-Device Identifier: 00801741036385
• UDI-Public: (01)00801741036385
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K830406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/15/2023

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
• Operator of Device: Health Professional
• Device Model Number: 0601610
• Device Catalogue Number: 0601610
• Device Lot Number: REFX4541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2023
• Supplement Date Received by Manufacturer: 04/04/2023; 06/15/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 04/16/2023; 06/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: UNKNOWN
• Patient Sequence Number: 1
• Patient Sex: Unknown