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

Model Number 0652034

Device Problem Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Date 10/13/2020

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a bent needle is confirmed but the exact cause remains unknown.One 20 ga x 0.75 in powerloc infusion set was returned for evaluation in open packaging.The packaging label indicated lot: asdyf081.A sharp bend was present on the needle shaft extending from the base.The safety mechanism was not activated.The plastic needle cover was present over the needle.No apparent evidence of use was noted on the device.Microscopic observation of the needle bevel did not reveal any apparent deformation that would suggest advancement against a solid surface.Damage on the proximal end of the plastic needle cover was also observed.The damage on the plastic needle cover likely occurred due to the compression of the needle against the safety base.An attempt to activate the safety mechanism was unsuccessful.An attempt to straighten the needle was made.The safety mechanism was able to successfully activate over the needle tip.Based on the condition of the returned sample, possible contributing factors include damage during storage or handling.Since the bend in the needle was present, the complaint is confirmed; however, the exact location and source of the damage remains unknown.A lot history review (lhr) of asdyf081 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by an oncology nurse that upon opening the package, the needle was found bent.No other information was provided.

• Brand Name: POWERLOC SAFETY 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 11155690
• MDR Text Key: 227748512
• Report Number: 3006260740-2020-21276
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741047763
• UDI-Public: (01)00801741047763
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0652034
• Device Catalogue Number: 0652034
• Device Lot Number: ASDYF081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2019
• 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