MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 1.0 IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problems Material Deformation (2976); Activation Problem (4042)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of asdrs0197 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that a needle would not lock to make it a safe sharp after use, it was further reported that the needle was bent.

Manufacturer Narrative

The information provided by bd represents all of 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.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of inability to activate the safety mechanism was confirmed and the cause was determined to be use related.The product returned for evaluation was a one 20ga x 1" powerloc max safety infusion set.The returned product sample was evaluated and the needle was observed to be bent at multiple points along the length of the needle shaft.The following observations were noted during the sample evaluation: usage residue was seen on the sample which proved that the product had experienced at least some use.The bend in the needle had occurred away from the needle base which can be caused by device manipulation during/following port access.The needle tip was barbed suggesting contact between the needle and port base a functional test of the safety mechanism found that the safety mechanism would not engage over the needle tip due to the bend within the needle.Force applied at an angle to the needle axis, or if the needle is not inserted perpendicular into the port septum, can lead to bending of the needle shaft.It is advised to verify that the needle length is correct based on port reservoir depth, tissue thickness and the thickness of any dressing beneath the bend of the needle; if too long, needle and/or port may be damaged at insertion.Additionally, avoid excessive manipulation once the needle is in the port.No potential damage related to the manufacturing process was noted on the complaint sample.A lot history review (lhr) of asdrs0197 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that a needle would not lock to make it a safe sharp after use, it was further reported that the needle was bent.

• Brand Name: POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 1.0 IN
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10313764
• MDR Text Key: 200042926
• Report Number: 3006260740-2020-02609
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741047442
• UDI-Public: (01)00801741047442
• Combination Product (y/n): N
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• 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: 0142010
• Device Lot Number: ASDRS0197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Event Location: Hospital
• Date Manufacturer Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1