MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX POWER-INJECTIBLE 22G X 0.75"; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	0132275
Date of Event	01/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.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 the tubing became unattached at the hub connection leaving an open pathway.No other information was provided.Additional information received 01/07/2021: was there patient harm reported?: caused re-access of a pediatric patient.
Event or Problem Description
It was reported the tubing became unattached at the hub connection leaving an open pathway.No other information was provided.Additional information received 01/07/2021: was there patient harm reported?: caused re-access of a pediatric patient.
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 infusion set was confirmed.The product returned for evaluation was five 22 ga x 0.75¿ powerloc max safety infusion sets.The first sample (sample 1) exhibited abundant usage residues.The remaining four samples were received in their sealed packages.Sample 1 exhibited a complete break at the luer/tubing joint.The sealed samples were unremarkable.Microscopic inspection of the break revealed a granular fracture surface.Beach marks and radiating tear marks were observed throughout the fracture surface.Material buckling and discoloration were observed in the vicinity of the break.The break characteristics and material buckling were consistent with material failure due to repetitive stress.It appeared that the tubing fractured, in part, due to repetitive torsional (twisting) stress, suggesting that securement, access and maintenance techniques may have contributed; however, it appeared that an additional unidentified factor(s) may have contributed.The supplier has been notified of this even.

• Brand Name: POWERLOC MAX POWER-INJECTIBLE 22G X 0.75"
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11251682
• Report Number: 3006260740-2021-00124
• Device Sequence Number: 19855781
• Product Code: FPA
• UDI-Device Identifier: 00801741047404
• UDI-Public: (01)00801741047404
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K073050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2021

1 Device 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: 0132275
• Device Catalogue Number: 0132275
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 01/29/2021
• Supplement Report FDA Received Date: 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No