MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX POWER-INJECTIBLE INFUSION SET 19G X 1.0 IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2021
Type of Reportable Event	Malfunction
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 needle was confirmed.The product returned for evaluation was three photographs which depicted a powerloc max safety infusion set.All three photographs depicted the needle housing and needle.In two of the photographs a portion of the extension tubing was visible.Usage residues were visible throughout the visible portion of the device.The safety mechanism was not activated.The needle tip was sharply barbed.The tip of the bevel curled back toward the needle shaft.The shaft appeared slightly bent at the exit site from the non-engaged safety mechanism.The needle tip deformation and shaft bend were consistent with damage caused by contact between the needle tip and a hard planar surface.Such damage can occur if a too-long needle is used to access the port and if the needle is forcefully pressed against the base of the indwelling port.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 ¿nurse was de-accessing vad and could not completely remove huber needle.Called charge nurse to the room.The cn stated she could see "meat" hung up on the needle so, she maneuvered the needle to unhook the flesh it was pulling on the way out.She was finally able to de-access the vad.Stated she could not activate the safety on the needle due to the deformity of the needle.This could have resulted in a "rebound" needle stick-(near miss).Vad inserted on 3 south-day 0 on (b)(6) 2021 at 7:35.Not sure where or when or at what point the needle was bent.¿.

• Brand Name: POWERLOC MAX POWER-INJECTIBLE INFUSION SET 19G X 1.0 IN
• 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: 12713030
• Report Number: 3006260740-2021-04608
• Device Sequence Number: 4703934
• Product Code: FPA
• UDI-Device Identifier: 00801741047329
• UDI-Public: (01)00801741047329
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2021

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: N/A
• Device Catalogue Number: 0131910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 10/28/2021
• 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: 73 YR
• Patient Weight: 90