MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC SAFETY INFUSION SET 20G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	8672034
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via phone call received informing of a bent needle.Upon questioning, i was informed a patient has a power port insitu, this was accessed for an elastomeric infusor and he returned to day oncology unit to have the port access needle flushed and removed, as treatment completed.Nurses had trouble removing needle as it appeared to be "stuck".Needle eventually removed and seen to be "bent".Reported was not bent upon insertion.Interventional radiology involved and reported no fragments were found.They did not check integrity of the silicon septum.Patient has been known to play with port and to re-access without medical/nursing help in the past.No other information provided, at this time.
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 manufacturer has received the sample and is pending evaluation.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported via phone call received informing of a bent needle.Upon questioning, i was informed a patient has a power port insitu, this was accessed for an elastomeric infusor and he returned to day oncology unit to have the port access needle flushed and removed, as treatment completed.Nurses had trouble removing needle as it appeared to be "stuck".Needle eventually removed and seen to be "bent".Reported was not bent upon insertion.Interventional radiology involved and reported no fragments were found.They did not check integrity of the silicon septum.Patient has been known to play with port and to re-access without medical/nursing help in the past.No other information provided, at this time.
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 complaint of a bent needle was confirmed and the cause was determined to be use related.The product returned for evaluation was a one 20ga x 0.75" powerloc max safety infusion set.The returned product sample was evaluated and the needle was observed to be bent at the exit site from the non-engaged safety mechanism.The following observations were noted during the sample evaluation: usage residue was seen on the sample which proved that the product had experienced at least some use.The needle tip was barbed suggesting contact between the needle and port base.An attempt to advance the safety over the needle tip was unsuccessful as the safety could not pass the bent region of the needle.Force applied at an angle to the needle axis, or if the needle is not inserted perpendicular into the port septum, can lead to bending of the needle shaft.It is advised to verify that the needle length is correct based on port reservoir depth, tissue thickness and the thickness of any dressing beneath the bend of the needle; if too long, needle and/or port may be damaged at insertion.Additionally, avoid excessive manipulation once the needle is in the port.No potential damage related to the manufacturing process was noted on the complaint sample.

• Brand Name: POWERLOC SAFETY INFUSION SET 20G X 0.75IN WITH Y-SITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer Contact: shelly gilbert ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20864858
• Report Number: 3006260740-2024-07254
• Device Sequence Number: 12884444
• Product Code: FPA
• UDI-Device Identifier: 00801741048425
• UDI-Public: (01)00801741048425
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K060812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2025

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: 8672034
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 04/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown