MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ LUER SLIP TIP SYRINGE STERILE, SINGLE USE,; PISTON SYRINGE

Model Number	309659
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E4: the initial reporter also notified the fda on 21-mar-2023.Medwatch report # mw5115971 h3: a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd¿ luer slip tip syringe sterile, single use foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: i noticed visible contamination on an unopened sterile bd 1 ml tuberculin slip-tip syringe (ref (b)(4)).The lot number is 2203500.Our lab uses these syringes in prokaryotic microbial research with no direct human health applications.I can't ascertain whether the residue is only on the outside of the syringe or actually inside the tip without opening the sterile wrapper.All i can say with certainty is that the discoloration is on the syringe itself, not just the inside of the packaging.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 26-apr-2023.H6: investigation summary: one sample was provided to our quality team for investigation.Through visual inspection, a brownish-red embedded spots were observed.Potential root cause for the embedded foreign matter defect is associated with the molding process.The embedded foreign matter is most likely degraded plastic.This occurs when the resin is exposed to prolonged high temperatures inside the molding machine, such as during start up.This type of defect is cosmetic and does not pose risk to the customer.A device history record review was completed for provided lot number 2203500.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.
Event or Problem Description
It was reported while using bd¿ luer slip tip syringe sterile, single use foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: i noticed visible contamination on an unopened sterile bd 1 ml tuberculin slip-tip syringe (ref (b)(4)).The lot number is 2203500.Our lab uses these syringes in prokaryotic microbial research with no direct human health applications.I can't ascertain whether the residue is only on the outside of the syringe or actually inside the tip without opening the sterile wrapper.All i can say with certainty is that the discoloration is on the syringe itself, not just the inside of the packaging.

• Brand Name: BD¿ LUER SLIP TIP SYRINGE STERILE, SINGLE USE,
• 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16781764
• Report Number: 1213809-2023-00389
• Device Sequence Number: 12475033
• Product Code: FMF
• UDI-Device Identifier: 30382903096597
• UDI-Public: (01)30382903096597
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2023

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 Model Number: 309659
• Device Catalogue Number: 309659
• Device Lot Number: 2203500
• 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: 03/30/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 05/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2022
• 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