MAUDE Adverse Event Report: BARD ACCESS SYSTEMS WINGED INFUSION SET WITH INJECTION SITE 22G X 0.75IN; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/17/2019
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) of recr2915 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "the needle extension was cut from the luer lock side".
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, complaint and lot history, applicable previous investigation(s) and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a split in the extension tubing is confirmed but the exact cause remains unknown.Two photo samples of a 22 ga x 0.75 in winged infusion set were also provided for investigation.The first photo sample shows the product packaging with the infusion set on the side.The lot number shows recr2915.No clear evidence of use or damage could be observed on the sample.The second photo shows the proximal luer with an infusion cap attached to 3-way connector.The extension tubing is broken distal to the hub.A section of the extension tubing is protruding from the hub which indicates the tubing likely broke.Based on the photo samples, possible contributing factors include securement technique, material fatigue, and excessive tensile force.A lot history review (lhr) of recr2915 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (recr2915) have been reported from the same facility in saudi arabia.
Event or Problem Description
It was reported "the needle extension was cut from the luer lock side".

• Brand Name: WINGED INFUSION SET WITH INJECTION SITE 22G 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: 8918866
• Report Number: 3006260740-2019-02452
• Device Sequence Number: 18895508
• Product Code: FMI
• UDI-Device Identifier: 00801741065873
• UDI-Public: (01)00801741065873
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K863606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2019

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: 2205222
• Device Lot Number: RECR2915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Initial Date Received by Manufacturer: 08/01/2019
• Supplement Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 10/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1