MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE INTEGRA 25X5/8 RB TW; PISTON SYRINGE

Model Number	305310
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7027897, medical device expiration date: 02/20/2017, device manufacture date: 12/31/2021.Medical device lot #: 7263635, medical device expiration date: 10/20/2017, device manufacture date: 08/31/2022.Medical device lot #: 9329608, medical device expiration date: 02/07/2021, device manufacture date: 01/31/2025.Investigation summary: it was reported that the needle detached from the syringe.To aid in the investigation, four shelf boxes with one hundred units each, three plastic bags with multiple samples and one photo were received for evaluation by our quality team.One hundred random samples were taken from the three plastic bags.A visual inspection was performed and no defects or imperfections were observed.Each sample was then connected to a syringe.No connectivity issues were detected.It could be possible the product is not being used correctly and resulting in the defect reported.A device history record review was completed for provided material number and lot numbers.The review did not reveal any detected quality issues during the production of these lots that could have contributed to the reported defect.To date, there have been no other similar events reported for these lots.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported multiple needle integra 25x5/8 rb tw had needles detaching from the syringe.The following information was provided by the initial reporter: "these are loose unused samples and approximately 100 samples.".

• Brand Name: NEEDLE INTEGRA 25X5/8 RB TW
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 12250018
• Report Number: 1911916-2021-00760
• Device Sequence Number: 4600343
• Product Code: MEG
• UDI-Device Identifier: 30382903053101
• UDI-Public: 30382903053101
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2021

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: Other
• Device Model Number: 305310
• Device Catalogue Number: 305310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1