MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BROVIAC CV CATHETER REPAIR KIT, SINGLE-LUMEN,WHITE, 6.6F; PORT AND CATHETER ACCESSORIES

Catalog Number 0601620CE

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 09/02/2022

Event Type  malfunction  

Manufacturer Narrative

The catalog number has not been cleared in the us but is similar to the broviac cv catheter repair kit, single-lumen,white, 6.6f that are cleared in the us.The pro code and 510 k number for the broviac cv catheter repair kit, single-lumen,white, 6.6f are identified in common device name.As the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.

Event Description

It was reported that during a catheter repair procedure, the metal pin of repair was allegedly detached from repair site.There was no reported patient injury.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the broviac cv catheter repair kit, single-lumen,white, 6.6f that are cleared in the us.The pro code and 510 k number for the broviac cv catheter repair kit, single-lumen,white, 6.6f are identified in d2 and g4.H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.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.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.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 : device not returned.

Event Description

It was reported that during a catheter repair procedure, the metal pin of repair was allegedly detached from repair site.There was no reported patient injury.

Manufacturer Narrative

The catalog number identified in section d4 has not been cleared in the us but is similar to the broviac cv catheter repair kit, single-lumen,white, 6.6f that are cleared in the us.The pro code and 510 k number for the broviac cv catheter repair kit, single-lumen,white, 6.6f are identified in d2 and g4.Manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one 6.6fr broviac s/l catheter repair kit was returned for evaluation.Gross visual, microscopic visual, tactile, functional and destructive evaluation were performed.The investigation is confirmed for the reported metal pin of repair was detached from repair site as a longitudinal split was made on the stiff portion on the distal end of the catheter where the metal pin was found inside the cut portion of the catheter.A definitive root cause could not be determined based upon the provided 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.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 sometime post catheter repair procedure, the metal pin of repair was allegedly detached from repair site.There was no reported patient injury.

• Brand Name: BROVIAC CV CATHETER REPAIR KIT, SINGLE-LUMEN,WHITE, 6.6F
• Type of Device: 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: 15866804
• MDR Text Key: 307324786
• Report Number: 3006260740-2022-05493
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K830406
• 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: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0601620CE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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