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

Model Number N/A

Device Problem Break (1069)

Patient Problem Laceration(s) (1946)

Event Date 07/12/2022

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refw1282 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by the customer "a powermidline kit was in use for a procedure and the clinician doing the placement opened the lidocaine vial and then went to set it in the holder in the sterile tray.Upon placing it into the holder the glass vial completely shattered in her hand and a piece of glass stuck directly into her finger." add info rcvd 07/22/2022: is the picture available to be shared? they were trying to place a picc so no they did not stop to take a picture of the incident.Event information provide details of the medical treatment provided (i.E.Medication(s) given, surgical interventions, hospitalization, future treatment plan, etc.¿).Removed piece of glass washed hands with soap and water applied bandaid, discarded the picc tray and opened a new tray to complete the picc insertion.Reported to manager, tetanus utd.Incident witnessed by vat line observer.Has there been a change in the patient¿s current treatment plan because of the event? no, injury was to employee not patient.

• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15196103
• MDR Text Key: 304194714
• Report Number: 3006260740-2022-03113
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: P4154108D
• Device Lot Number: REFW1282
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• 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