MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HICKMAN CV CATHETER, DUAL-LUMEN REPAIR KIT, RED/WHITE, 9F; PORT AND CATHETER ACCESSORIES

Catalog Number 0601700CE

Device Problems Loss of or Failure to Bond (1068); Device Dislodged or Dislocated (2923)

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

Event Date 03/01/2022

Event Type  malfunction  

Event Description

It was reported that during a catheter placement procedure, the device allegedly dislodged.It was further reported that the one of the stent migrated from repair kit.The procedure was completed using same device.There was no reported patient injury.

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the hickman cv catheter, dual-lumen repair kit, red/white, 9f products that are cleared in the us.The pro code and 510 k number for the hickman cv catheter, dual-lumen repair kit, red/white, 9f products are identified.Manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the sample was not returned for evaluation, three electronic photos and one medical image review were provided for review.The photos shows one hickman catheter and it was noted that, two regions of the catheter was appeared to be repaired.Another photo shows a closer view of older repaired junction.Stents were also seen on the provided photo.Furthermore, the medical image shows a catheter displayed on a table and there are multiple points along the catheter that appear fractured/damaged.Therefore, the investigation is inconclusive for the reported stent migration and loss of or failure to bond issues as poor photograph sample evidences were provided and the exact circumstances at the time of reported event was unknown.However, clinical conditions alleged in the complaint cannot be verified from the provided photo and image 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.Device not returned.

Event Description

It was reported that during a catheter placement procedure, the device allegedly dislodged.It was further reported that the one of the stent migrated from repair kit.The procedure was completed using same device.There was no reported patient injury.

Manufacturer Narrative

H10: the initial mdr was inadvertently submitted with a g3 date of 10/27/2022.The correct g3 date is 05/12/2022.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the hickman cv catheter, dual-lumen repair kit, red/white, 9f products that are cleared in the us.The pro code and 510 k number for the hickman cv catheter, dual-lumen repair kit, red/white, 9f products are identified in d2 and g4.H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.However, an image and photos were provided for review.The investigation of the reported event is currently underway.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 placement procedure, the device allegedly dislodged.It was further reported that one of the stent migrated from repair kit.The procedure was completed using same device.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 hickman cv catheter, dual-lumen repair kit, red/white, 9f products that are cleared in the us.The pro code and 510 k number for the hickman cv catheter, dual-lumen repair kit, red/white, 9f products 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 sample was not returned for evaluation.However, three electronic photos and one medical image review were provided for review.The photos shows one hickman catheter and it was noted that, two regions of the catheter was appeared to be repaired.Another photo shows a closer view of older repaired junction.Stents were also seen on the provided photo.Furthermore, the medical image shows a catheter displayed on a table and there are multiple points along the catheter that appear fractured/damaged.Therefore, the investigation is inconclusive for the reported stent migration and loss of or failure to bond issues as poor photograph sample evidences were provided and the exact circumstances at the time of reported event was unknown.However, clinical conditions alleged in the complaint cannot be verified from the provided photo and image 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.

• Brand Name: HICKMAN CV CATHETER, DUAL-LUMEN REPAIR KIT, RED/WHITE, 9F
• 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: 15850339
• MDR Text Key: 307294170
• Report Number: 3006260740-2022-05474
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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: 06/22/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 0601700CE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2022
• Initial Date FDA Received: 11/23/2022
• Supplement Dates Manufacturer Received: 12/30/2022; 06/22/2023
• Supplement Dates FDA Received: 01/17/2023; 06/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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