MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC SAFETY INFUSION SET 20G X 1 IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of asdns0020 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that a small hole in the tubing under the needle was observed when flushing port.No other information was provided.
Additional Manufacturer Narrative
6/26/2019 - 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 a leaking infusion set was confirmed and the cause appeared to be supplier-related.The product returned for evaluation was one 20ga x 0.75¿ powerloc safety infusion set.Usage residues were observed throughout the sample and the safety mechanism was engaged.A small split was observed at the joint between the extension tubing and the needle housing.Curved shape memory was observed in the vicinity of the split.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion; however, a leak was observed emanating from the site of the aforementioned split.Microscopic inspection of the split revealed dully granular fracture edges.Material abrasion and buckling were observed in the vicinity of the split.The split characteristics and curved shape memory were consistent with damage caused by device manipulation; however, the observed flaw in the tubing appeared to have contributed to device susceptibility to damage.The device is a supplied component and the supplier has been notified of this event.
Event or Problem Description
It was reported that a small hole in the tubing under the needle was observed when flushing port.No other information was provided.

• Brand Name: POWERLOC SAFETY INFUSION SET 20G X 1 IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8629882
• Report Number: 3006260740-2019-01440
• Device Sequence Number: 13922271
• Product Code: FPA
• UDI-Device Identifier: 00801741047749
• UDI-Public: (01)00801741047749
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K060812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0652010
• Device Lot Number: ASDNS0020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 07/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1