MAUDE Adverse Event Report: BARD ACCESS SYSTEMS WINGED INFUSION SET WITH INJECTION SITE 22G X 1 IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that when the wis was opened, it was noted that connector on one of the ports was missing and hence didn¿t use the needle.They tried closing the needle with regular end cap but didn¿t find it tight enough as saline was leaking.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a missing end cap is inconclusive due to the state of the sample was returned in.One 22 g x 1 in.Winged infusion set with a y-site was returned for evaluation.An initial visual observation showed no cap was returned on the y-site.An end cap was returned on the proximal luer connector and a protective cover was returned on the needle.No blood residue was observed on the sample; however, a white, crystalline residue was observed within the proximal luer hub.The sample was flushed and pressurized with a 12 ml syringe of water and was found to be patent to infusion and aspiration and no leaks were observed.Leakage was observed from the y-site when the returned end cap was attached to the luer of the y-site; however, when a non-complainant silicone end cap was attached to the luer of the y-site no leakage was observed.A microscopic observation revealed the treads of the returned end cap were damaged.Because the sample was returned outside of any sealed packaging, it was difficult to assess when or where the infusion cap may have gone missing; therefore, this complaint is inconclusive.A lot history review (lhr) of reat1791 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that when the wis was opened, it was noted that connector on one of the port was missing and hence didn¿t use the needle.They tried closing the needle with regular end cap but didn¿t find it tight enough as saline was leaking.

• Brand Name: WINGED INFUSION SET WITH INJECTION SITE 22G X 1 IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8804260
• Report Number: 3006260740-2019-02043
• Device Sequence Number: 18946735
• Product Code: FMI
• UDI-Device Identifier: 00801741065903
• UDI-Public: (01)00801741065903
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K863606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2019

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: 2206222
• Device Lot Number: REAT1791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/29/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1