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

Model Number 0601700

Device Problem Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/08/2022

Event Type  Injury  

Manufacturer Narrative

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 catheter placement procedure, the metal segment of the repair kit allegedly migrated.Current status of the patient is unknown.

Manufacturer Narrative

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: h6 (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.H3 other text: device not returned.

Event Description

It was reported that during catheter placement procedure, the metal segment of the repair kit allegedly migrated.Current status of the patient is unknown.

• 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: 15501671
• MDR Text Key: 300761546
• Report Number: 3006260740-2022-03793
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741036439
• UDI-Public: (01)00801741036439
• 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
• Report Date: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0601700
• Device Catalogue Number: 0601700
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2022
• 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
• Patient Outcome(s): Required Intervention