MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 1.0 IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2022
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) of asfwf093 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by healthcare professional "event happened when a nurse was deaccessing a port today.She was holding it properly and went to pull the needle back and it snapped off.No injury to staff or patient.".
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, complaint and batch history, applicable previous investigation(s), photo analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint that the safety mechanism detached from the infusion set was confirmed but the cause is unknown.A single photograph of a damaged powerloc max safety infusion set was returned for evaluation.The safety mechanism had completely detached from the infusion set needle.The tip of needle appeared to contain the manufactured bend and the yellow safety mechanism base was present in the safety mechanism housing.Microscopic examination, functional testing, and dimensional analysis could not be conducted without the physical sample.Therefore, the failure between the components could be confirmed but the exact root cause could not be determined.
Event or Problem Description
It was reported by healthcare professional "event happened when a nurse was deaccessing a port today.She was holding it properly and went to pull the needle back and it snapped off.No injury to staff or patient.".

• Brand Name: POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G 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
• Manufacturer (Section G): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer Contact: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13721633
• Report Number: 3006260740-2022-00656
• Device Sequence Number: 11939773
• Product Code: FPA
• UDI-Device Identifier: 00801741047442
• UDI-Public: (01)00801741047442
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K153440
• 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): 04/15/2022

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: 0142010
• Device Lot Number: ASFWF093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/18/2022
• Supplement Date Received by Manufacturer: 04/15/2022
• Initial Report FDA Received Date: 03/10/2022
• Supplement Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• 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