MAUDE Adverse Event Report: BARD ACCESS SYSTEMS WINGED INFUSION SET 20G X 0.75IN; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	0604190
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/31/2018
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, at this time, to the manufacturer for evaluation.A lot history review (lhr) of recs1177 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (recs1177) have been reported from the same facility in (b)(6).Device has not yet been returned for evaluation.
Event or Problem Description
It was reported that the infusion set was fractured.The infusion was stopped and the infusion set was removed.No reported patient injury.
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 fracture in the infusion set line was inconclusive since the damaged sample was apparently not returned.Six 20g x ¾¿ winged infusion sets were returned for investigation.Five were received in sealed pouches.One was received without its packaging, but appeared to be unused.No residue was observed on the sample and the dust cap was attached to the luer hub.It was reported that infusion was stopped and the infusion set removed, which indicates that the product was used.A functional test revealed no breaches in the infusion sets that were returned for investigation.Since the problem could not be reproduced and since the damaged sample was apparently not returned for investigation, the complaint was inconclusive.A lot history review (lhr) of recs1177 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (recs1177) have been reported from the same facility in the (b)(6).
Event or Problem Description
It was reported that the infusion set was fractured.The infusion was stopped and the infusion set was removed.No reported patient injury.

• Brand Name: WINGED INFUSION SET 20G X 0.75IN
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7936879
• Report Number: 3006260740-2018-02728
• Device Sequence Number: 1937066
• Product Code: FMI
• UDI-Device Identifier: 00801741065804
• UDI-Public: (01)00801741065804
• Combination Product (Y/N): N
• PMA/510(K) Number: K863606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2018

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 Model Number: 0604190
• Device Catalogue Number: 0604190
• Device Lot Number: RECS1177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1