MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC SAFETY INFUSION SET 20G X 0.75IN WITH Y-SITE; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	0672034J
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of asbws0126 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that upon opening the package, the needle protect cover came off the needle and dropped.The operator complained that s/he stopped using the device because its wing part was apart from the shield base and its needle was exposed and unstable.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of the needle cover coming off and the safety mechanism detached from the needle housing is confirmed; however the exact cause is unknown.One 20 g x 0.75 in.Powerloc with y-site was returned for evaluation.An initial visual observation showed some use residue one the returned sample.The protective cover was returned off of the needle.One of the barbs on the bottom of the needle housing was observed to be severely bent.A microscopic observation revealed lightening of the material at the bend in the barb of the needle housing, indicating the barb was bent by force and was not a molding defect.It was observed that the safety mechanism was position further down the needle cannula than normal due to the bent barb, which could have allowed the protective cover to fall off of the needle.It is possible that the force which caused the bend the barb on the needle housing was applied during manufacturing, storage, or use.A lot history review (lhr) of asbws0126 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that upon opening the package, the needle protect cover came off the needle and dropped.The operator complained that s/he stopped using the device because its wing part was apart from the shield base and its needle was exposed and unstable.

• Brand Name: POWERLOC SAFETY INFUSION SET 20G X 0.75IN WITH Y-SITE
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7468185
• Report Number: 3006260740-2018-00830
• Device Sequence Number: 13757001
• Product Code: LJT
• UDI-Device Identifier: 00801741151477
• UDI-Public: (01)00801741151477
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2018

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: 0672034J
• Device Lot Number: ASBWS0126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 04/27/2018
• Supplement Report FDA Received Date: 05/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1