MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC PORT ACCESS KIT 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2652034
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
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 reex1602 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the safety infusion set needles didn't retracted when removed from the patients, causing a safety risk to the infusion nurses.
Event or Problem Description
It was reported the safety infusion set needles didn't retracted when removed from the patients, causing a safety risk to the infusion nurses.
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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint that the safety mechanism wouldn¿t activate was inconclusive due to the sample condition and could not be verified from the six photographs that were provided for investigation.One photo showed the product label with part number 2652034 and lot reex1602.The other five photos showed the safety mechanism partially activated over the needle.The distal end of the needle extended from the safety mechanism.The arms on the safety mechanism were not fully extended.The safety mechanism was not pulled into and locked within the translucent wings.The orange tab was not folded over the needle tip.The photos showed that the safety mechanism was not fully activated; however, it could not be determined if the safety mechanism was inhibited from full activation or if the needle was not fully pulled up when deaccessing.The instructions for use (ifu) states, ¿firmly pull the wings up until you hear or feel a ¿click¿.An orange dot is also provided on the safety mechanism as a visual method to know when the needle is safe.

• Brand Name: POWERLOC PORT ACCESS KIT 20G X 0.75IN
• 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: 11865841
• Report Number: 3006260740-2021-01944
• Device Sequence Number: 19730346
• Product Code: FPA
• UDI-Device Identifier: 00801741044472
• UDI-Public: (01)00801741044472
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K060812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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: 2652034
• Device Catalogue Number: 2652034
• Device Lot Number: REEX1602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 07/07/2021
• 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