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 Consequences Or Impact To Patient (2199)
Date of Event	07/23/2019
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 during administration of medicines from the connector at the y site and administration of tpn from the connector at the extension tube simultaneously, leakage from the y site was found approximately two hours after the start of administration.When the powerloc was removed and water was injected using a 6cc syringe, a crack was found at the y site.There was no reported patient injury.
Additional Manufacturer Narrative
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 and the safety mechanism was engaged.A longitudinally aligned split was observed in the y-site luer adapter.Several longitudinally aligned stress fractures were observed throughout the y-site luer.Microscopic inspection of the y-site luer adapter confirmed the presence of a split.The split exhibited a granular fracture surface and sharply defined features.Material discoloration was observed throughout y-site luer.They threads were unremarkable.The material discoloration, stress fractures and split orientation were consistent with damage caused by outward radiating stress within the luer orifice.The undamaged threads suggested that forceful insertion of a tapered object into the luer may have contributed; however, attempts to replicate the damage using non-complainant devices were unsuccessful, suggesting that an addition contributing factor(s) contributed.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.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 during administration of medicines from the connector at the y site and administration of tpn from the connector at the extension tube simultaneously, leakage from the y site was found approximately two hours after the start of administration.When the powerloc was removed and water was injected using a 6cc syringe, a crack was found at the y site.There was no reported patient injury.

• 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: 8896977
• Report Number: 3006260740-2019-02404
• Device Sequence Number: 11361934
• 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): 09/11/2019

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: 08/07/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1