MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX POWER-INJECTIBLE INFUSION SET 22G X 1IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
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	12/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of asetf021 showed no other similar product complaint(s) from this lot number.Device not returned for evaluation.
Event or Problem Description
It was reported powerloc needle tubing cracked.Additional details received 01/12/2021 via phone call with the patient: it was reported "the tubing was severed by the hub where the plastic meets the tubing.This is the only time that we used this needle.This is a new port, i have used other brands of needles before and since, i never have had a problem only with this needle.".
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 one 22ga x 0.75¿ powerloc max safety infusion set.Usage residues were observed throughout the sample and the safety mechanism was engaged.A complete break was observed in the extension tubing at the luer/tubing joint.Microscopic inspection of the break revealed a granular fracture surface.Beach marks and radiating tear marks were observed throughout the break surface.Material buckling and discoloration were observed in the vicinity of the break.The break features were consistent with material failure due to fatigue.Fatigue occurs when repetitive mechanical stresses such as twisting and kinking gradually cause a fracture to form and propagate in the material; however, additional factors appear to have contributed.The device is a supplied component and the supplier has been notified of this event.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported powerloc needle tubing cracked.Additional details received via phone call with the patient: it was reported "the tubing was severed by the hub where the plastic meets the tubing.This is the only time that we used this needle.This is a new port, i have used other brands of needles before and since, i never have had a problem only with this needle." additional information received: "a detailed description of the event: when the patient tried to access her port, the powerloc max huber needle tubing split.Patient could not access her port, and her medication could not be administered." "was there patient harm reported? no direct patient harm was reported with this incident.Patient was emotionally distraught, as she has had this occur with the last recall, and she ended up needing a surgical replacement of her port.She was also unable to administer her medication until a nurse was able to emergently see her.".

• Brand Name: POWERLOC MAX POWER-INJECTIBLE INFUSION SET 22G X 1IN
• 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: 11171580
• Report Number: 3006260740-2020-21314
• Device Sequence Number: 3719072
• Product Code: FPA
• UDI-Device Identifier: 00801741047473
• UDI-Public: (01)00801741047473
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K073050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

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 Expiration Date: 06/05/2023
• Device Model Number: N/A
• Device Catalogue Number: 0142210
• Device Lot Number: ASETF021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 07/01/2021
• 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: 34 YR
• Patient Weight: 68