MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC SAFETY INFUSION SET 20G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/08/2019
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) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that when heparinized saline solution was injected into the powerloc to lock the port system, there was a crack at the y site of the powerloc and heparinized saline solution leaked from the crack.There was no reported patient injury.
Event or Problem Description
It was reported that when heparinized saline solution was injected into the powerloc to lock the port system, there was a crack at the y site of the powerloc and heparinized saline solution leaked from the crack.There was no reported patient injury.
Additional Manufacturer Narrative
H11:section a through f - 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 a damaged y-site was confirmed; however, the root cause was not identified.The product returned for evaluation was one 20ga x 0.75¿ powerloc safety winged infusion set with y-site.Usage residues were observed throughout the sample.A longitudinally aligned split was observed in the y-site luer adapter, near the proximal end.Multiple longitudinally aligned superficial stress cracks were observed.Microscopic inspection of the split revealed a granular fracture surface.The threads appeared unremarkable.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.Attempts to replicate the observed damage using a non-complainant infusion set were unsuccessful.The stress fractures and split suggested that the y-site was subjected to outward radiating stress.The undamaged threads suggested that forceful insertion of a slip-fit stylet accessory likely contributed; however, the damage could not be replicated, suggesting that an additional unidentified factor(s) contributed.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.

• Brand Name: POWERLOC SAFETY INFUSION SET 20G X 0.75IN WITH Y-SITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8846105
• Report Number: 3006260740-2019-02227
• Device Sequence Number: 16666209
• Product Code: FPA
• UDI-Device Identifier: 00801741151477
• UDI-Public: (01)00801741151477
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2019

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: 0672034J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1