MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Material Twisted/Bent (2981)

Patient Problem Discomfort (2330)

Event Date 11/14/2022

Event Type  malfunction  

Event Description

It was reported by healthcare professional the nurse attempted to access the port with powerloc max needle.Once the needle touched the silicon part, it immediately bent.The nurse had to remove the needle immediately and replaced it with a new needle without complication.Additional information provided: there was no medical intervention, intubation, or unusual circumstances.The device was not re-sterilized or re-processed.Device was not tested prior to use.An additional device was required.(b)(6) 2023 - the returned sample exhibited a bent needle.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, complaint and batch history, sample analysis, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a bent needle was confirmed but the exact cause remains unknown.The product returned for evaluation was a one 22 ga x 0.75 in powerloc max infusion set.The returned product sample was evaluated and the needle was observed to be bent at the needle shaft the following observations were noted during the sample evaluation: the sample appeared free of obvious use residue.The tip of the needle bevel appeared unremarkable.An attempt to advance the safety over the needle tip was unsuccessful as the safety could not pass the bent region of the needle.Based on the evidence provided with the returned sample it is unknown when or how the bend occurred in the needle.Damage to the needle could have occurred at the manufacturing facility, during shipping, during use, or during storage of the product, and no evidence was observed which supported a specific root cause of the event.A batch history review (bhr) of asfvf029 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16444620
• MDR Text Key: 310336539
• Report Number: 3006260740-2023-00561
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741047466
• UDI-Public: (01)00801741047466
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• 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: 0142075
• Device Lot Number: ASFVF029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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