MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SLIP TIP¿ SYRINGE WITH BD SAFETYGLIDE¿ SAFETY NEEDLE; PISTON SYRINGE

Catalog Number	309625
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd slip tip¿ syringe with bd safetyglide¿ safety needle experienced foreign matter on the needle.The following information was provided by the initial reporter: clump of white hard matter on needle.Type of incident/problem: defect (detected before use).Level of harm: no effect - did not reach patient - detected before use or does not touch person during use.
Additional Manufacturer Narrative
The following fields were updated due to additional information: device available for eval yes, returned to manufacturer on: 22-jun-2023 investigation summary one sample was provided to our quality team for investigation.Through visual inspection, it was observed that the sample has a hard white clump on the cannula 1/3 of the way from the tip.It appears to be epoxy used in the cannula to needle hub adhesive.This defect could occur if there was a jam occurred at the cannulator inducing the epoxy drip over on the needle.A device history record review showed no rejected inspections or quality issues during the production of the provided batch number that could have contributed to the reported defect.
Event or Problem Description
It was reported that the bd slip tip¿ syringe with bd safetyglide¿ safety needle experienced foreign matter on the needle.The following information was provided by the initial reporter: clump of white hard matter on needle type of incident/problem: defect (detected before use) level of harm: no effect - did not reach patient - detected before use or does not touch person during use.

• Brand Name: BD SLIP TIP¿ SYRINGE WITH BD SAFETYGLIDE¿ SAFETY NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16950696
• Report Number: 1213809-2023-00520
• Device Sequence Number: 17010940
• Product Code: FMF
• UDI-Device Identifier: 00382903096251
• UDI-Public: (01)00382903096251
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

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 Expiration Date: 01/31/2025
• Device Catalogue Number: 309625
• Device Lot Number: 0045377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2023
• Supplement Date Received by Manufacturer: 07/17/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown