MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT,4FR POWERMIDLINE; MIDLINE CATHETER

Model Number N/A

Device Problem Material Frayed (1262)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/03/2021

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refv3375 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported via medwatch " adult male with history of chronic kidney disease stage iii, chronic pain, covid-19 pneumonia admitted during fall 2021 with acute hypoxic respiratory failure due to covid pneumonia.Vascular access rn was placing a midline catheter on pt in right upper extremity (rue) cephalic vein.Access to vein obtained and wire threaded into needle.Upon threading wire, resistance was noted so wire was pulled out.Wire was reinserted without resistance for approximately 8cm and then resistance was met again.Wire pulled back a second time, but rn met resistance when pulling back.Needle removed and the rest of the wire came with it but was unraveled.Manager and md notified, x-ray obtained of the arm, and it was identified that a 2-inch piece was m the superficial tissue of the arm.The decision made to not retrieve the retained portion due to the status of this patient.Peripheral iv placed.No device nor packaging retained." add info rcvd 03/02/2022: are radiographic images available? here is the finding on that radiograph from the incident: there is a piece of wire projecting over the mid shaft of the humerus consistent with a fragment of the introducer wire for the picc catheter.Impression: wire fragment retained in the soft tissues.Has the patient required surgery to remove the retained piece?: no, it was decided to leave the piece due to the patient's medical condition.Has all the missing/broken pieces retrieved and accounted for?: no.Retained in patient.(see item directly above) any long-term patient harm?: this device retention was highly likely to be non-contributory to any patient harms as this patient was extremely compromised when he presented and due to his severe co-morbidities he expired 2 days after this picc insertion.

• Brand Name: DOT,4FR POWERMIDLINE
• Type of Device: MIDLINE CATHETER
• 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13809228
• MDR Text Key: 287411139
• Report Number: 3006260740-2022-00859
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741108761
• UDI-Public: (01)00801741108761
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: P4154108D
• Device Lot Number: REFV3375
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2021
• 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): Other
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Race: White