MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I. IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0602850
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.Expiry date (10/2023).
Event or Problem Description
It was reported that during a port placement, the catheter needle was allegedly broken.The procedure was completed using another port.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: this is the first complaint reported to date for this product and lot, therefore a device history review is not required.Investigation summary: one m.R.I.Port, one catheter, one flushing connector, one introducer needle, one straight non-coring needle, one right-angle non-coring needle, one vein pick, two catheter locks, one guidewire in a guidewire hoop, one introducer peel-apart sheath and vessel dilator, one safety infusion set, two luer caps, and one tunneler were returned for evaluation.Gross, microscopic visual and functional testing were performed.The investigation is confirmed for the reported needle break issue as multiple cracks were observed on the proximal needle hub.Leaks from the needle hub were observed upon infusion of the device; the needle was only able tp aspirate air within the syringe.A definitive root cause could not be determined.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: 07/2024), g3.H11: h6 (results and conclusion), e3.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.
Event or Problem Description
It was reported that during a port placement, the catheter needle was allegedly broken.The procedure was completed using another port.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 records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiry date: 07/2024).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.
Event or Problem Description
It was reported that during a port placement, the catheter needle was allegedly broken.The procedure was completed using another port.There was no reported patient injury.

• Brand Name: M.R.I. IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11009815
• Report Number: 3006260740-2020-20923
• Device Sequence Number: 4496371
• Product Code: LJT
• UDI-Device Identifier: 00801741025754
• UDI-Public: (01)00801741025754
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K873213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/02/2021

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: 0602850
• Device Catalogue Number: 0602680
• Device Lot Number: REDZ3189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 04/27/2021; 07/19/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 05/21/2021; 07/21/2021
• 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
• Patient Age: 62 YR