MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC SAFETY INFUSION SET 22G X 0.75IN; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	0652234
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 asbss0147 showed one other similar product complaints from this lot number.(b)(4).
Event or Problem Description
It was reported that the clinician found fluid/condensation in the tubing before it was used.
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 a fluid within the tubing of an infusion set is confirmed and was determined to be supplier related.One 22 g x 0.75 in.Powerloc winged infusion set was returned for evaluation.An initial visual observation showed a small amount of clear fluid within the tubing of the returned sample and within the needle guard on the needle shaft.No use residue was observed on the returned sample.The tubing was cut in order to extract some of the clear fluid.The fluid was observed to be slick and did not evaporate after it was spread thinly and left exposed under a light for 5 minutes.The observed properties of the fluid found in the tubing on the needle of the infusion set suggest the fluid is excess of an inert silicone lubricant that is applied to the needle during the manufacturing process to assist in the insertion of the needle during use.A lot history review (lhr) of asbss0147 showed one other similar product complaints from this lot number.(b)(4).
Event or Problem Description
It was reported that the clinician found fluid/condensation in the tubing before it was used.

• Brand Name: POWERLOC SAFETY INFUSION SET 22G X 0.75IN
• 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: 7541213
• Report Number: 3006260740-2018-01093
• Device Sequence Number: 205201
• Product Code: LJT
• UDI-Device Identifier: 00801741047794
• UDI-Public: (01)00801741047794
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K060812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2018
• Report Date (Section F): 05/02/2018

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: 0652234
• Device Lot Number: ASBSS0147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/31/2018
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 09/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1