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

Model Number	0132275
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.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 the tubing became unattached at the hub connection leaving an open pathway.Additional information received 1/7/2021: it was reported the pediatric patient had to be re-accessed but no harm was reported.
Event or Problem Description
It was reported the tubing became unattached at the hub connection leaving an open pathway.Additional information received 1/7/2021: it was reported the pediatric patient had to be re-accessed but no harm was reported.
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 infusion set was confirmed.The product returned for evaluation was five 22 ga x 0.75¿ powerloc max safety infusion sets with y-sites.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 y-site/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.H3 other text : evaluation findings are in section h.11.

• 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: 11205585
• Report Number: 3006260740-2021-00041
• Device Sequence Number: 17105301
• 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: company representative,other
• 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

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: 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: 12/31/2020
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 01/20/2021
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 11 MO
• Patient Weight: 11