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 Problem Fail-Safe Did Not Operate (4046)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Date 05/29/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint was inconclusive since the product was not returned for evaluation.Based on the description of the reported event, some possible contributing factors include; however, the lack of a returned sample prevented both confirmation of the reported event and identification of a root cause(s).Consequently, this complaint is inconclusive at this time.The complaint of a damaged safety mechanism is unconfirmed since no issues were observed with the returned sample.One 20 ga x 1 in powerloc infusion set was returned for investigation.Use residue was present over the needle.Microscopic observation revealed the needle tip to not be barbed.The safety mechanism was not activated.The safety mechanism was advanced and was able to be fully activated and locked in place.The needle tip did not protrude past the safety mechanism once activated.Since no issues were observed during functional testing of the returned sample, the complaint is unconfirmed.The product ifu provides illustrations and directions on how to de-access using the device.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported via medwatch that patient's dual port with 2 huber needles with swab caps de-accessed by rn.First gripper slowly de-accessed without any difficulty and the needle clicked into the securement device.The second huber gripper was de-accessed and looked like it was fully locked, but it was found after the needle was sticking out about 1/2 cm.Rn unsure if needle slipped back from the securement device, or it did not click properly.Needle stick occurred when rn picked up the huber needles to dispose them in sharps container.During picking up process, needle flopped and stuck n in the palm of the right hand.

• 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
• Manufacturer (Section G): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 8746030
• MDR Text Key: 150171321
• Report Number: 3006260740-2019-01829
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741047350
• UDI-Public: (01)00801741047350
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/07/2019,06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• 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: 0132010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/07/2019
• Distributor Facility Aware Date: 05/29/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/07/2019
• Date Manufacturer Received: 06/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 49 YR
• Patient Weight: 72