MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HICKMAN SINGLE LUMEN CATHETERS; CHRONIC CATHETERS

Model Number	0600040
Medical Device Problem Codes	Burst Container or Vessel (1074); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 catheter fracture issue, 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.
Event or Problem Description
It was reported that some time post a catheter placement, a crack was allegedly found on the catheter.There was no reported patient injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 12/2021), g3.H11: d4(medical device lot number), 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 or Problem Description
It was reported that some time post a catheter placement, a crack was allegedly found on the catheter.There was no reported patient injury.
Event or Problem Description
It was reported that some time post a catheter placement, a crack was allegedly found on the catheter.There was no reported patient injury.
Additional 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: the physical sample was not returned for evaluation, ten electronic photos were provided for review.The photos shows one hickman s/l catheter in two segments.A complete circumferential break was noted on the catheter distal to the tissue cuff.A c-shaped longitudinal split migrating from the edge complete circumferential break was noted on both the catheter segments.A snare like wire was hooked on to the longitudinal split of the distal catheter segment.Therefore the investigation is confirmed for the identified catheter burst issue as a c-shaped split was noted on the catheter.However, the investigation is unconfirmed for the reported fracture issue.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: 12/2021), g3, h6 (device, method) h11: section a through f ¿ the information provide 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.

• Brand Name: HICKMAN SINGLE LUMEN CATHETERS
• Common Device Name: CHRONIC CATHETERS
• 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: 12541057
• Report Number: 3006260740-2021-04009
• Device Sequence Number: 19650836
• Product Code: LJS
• UDI-Device Identifier: 00801741036309
• UDI-Public: (01)00801741036309
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K830256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/22/2022

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: 0600040
• Device Catalogue Number: 0600040
• Device Lot Number: REBN0649
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 02/01/2022; 05/10/2022
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 02/28/2022; 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2017
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown