MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC SAFETY INFUSION SET 22G X 0.75IN; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	0652234
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of asbss0147 showed no other similar product complaint(s) from this lot number.(b)(4).
Event or Problem Description
It was reported that the needle broke during the port access procedure.
Additional Manufacturer Narrative
The initial complaint appeared to be a reportable occurrence.Once the sample was returned and evaluated it was determined that a reportable event had not occurred.The information provided does not reasonably suggest the event may have caused or contributed to a death or serious injury of a patient, user or other person.If this event were to recur, it does not pose an incremental risk of harm to the patient, user, or other person.Therefore this event is deemed not reportable per 21 cfr part 803.(b)(4).
Event or Problem Description
It was reported that the needle broke during the port access procedure.9/17/2018 - the returned needle was bent, not broken.

• Brand Name: POWERLOC SAFETY INFUSION SET 22G X 0.75IN
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7541137
• Report Number: 3006260740-2018-01092
• Device Sequence Number: 178067
• Product Code: LJT
• UDI-Device Identifier: 00801741047794
• UDI-Public: (01)00801741047794
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K060812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2018
• Report Date (Section F): 05/02/2018

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 Catalogue Number: 0652234
• Device Lot Number: ASBSS0147
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 09/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1