MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HICKMAN CV CATHETER, DUAL-LUMEN,12F; CHRONIC CATHETERS

Model Number	0600620
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 01/2024).
Event or Problem Description
It was reported that some time post catheter placement, the catheter allegedly had an hole on plastic hub which is next to white lumen.It was further reported that catheter was removed and placed another catheter.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: one hickman 12.5 fr d/l catheter was returned for evaluation.Gross, microscopic visual and functional testing were performed.The investigation is confirmed for the reported whole in white lumen issue as a pinhole was noted just distal of the white luer.The pinhole noted just distal to the white luer on the white extension leg had jagged edges and appeared to penetrate through to the inner catheter.Both lumens were patent to infusion and aspiration.Upon clamping the white extension leg on the "clamp here" section of the catheter, a leak from the pinhole was observed.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: 01/2024), h11: b5, h6(patient, method, 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 : see h10.
Event or Problem Description
It was reported that during preparation of a catheter placement, the catheter allegedly had a hole on plastic hub which is next to white lumen.It was further reported that catheter was removed and placed another catheter.There was no reported patient contact.

• Brand Name: HICKMAN CV CATHETER, DUAL-LUMEN,12F
• Common Device Name: CHRONIC CATHETERS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11452408
• Report Number: 3006260740-2021-00762
• Device Sequence Number: 3497300
• Product Code: LJS
• UDI-Device Identifier: 00801741051913
• UDI-Public: (01)00801741051913
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2021

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: 0600620
• Device Catalogue Number: 0600620
• Device Lot Number: HUDS2618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other