MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ LUER SLIP TIP SYRINGE GAMMA IRRADIATED (LOW DOSE), 10 ML; PISTON SYRINGE

Model Number	304406
Medical Device Problem Codes	Leak/Splash (1354); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Address information was not able to be obtained, therefore, (b)(6) was used as a place holder.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 while using a bd¿ luer slip tip syringe gamma irradiated (low dose), 10 ml, leakage and a crack in syringe barrel was observed.The following information was provided by the initial reporter: leakage was detected during priming.It was observed one crack approximately 0.55" in length at the tip of the syringe barrel.Leakage occurred from the crack on syringe barrel.
Event or Problem Description
It was reported that while using a bd¿ luer slip tip syringe gamma irradiated (low dose), 10 ml, leakage and a crack in syringe barrel was observed.The following information was provided by the initial reporter: leakage was detected during priming.It was observed one crack approximately 0.55" in length at the tip of the syringe barrel.Leakage occurred from the crack on syringe barrel.
Additional Manufacturer Narrative
H6: investigation summary: two pictures of a 10ml luer-lok syringe (p/n 304406) were received and evaluated.One picture shows a crack in the roof of the barrel and the other shows leakage at the connection.The observed condition is non-conforming to our product specification.Potential root cause for the cracked barrel defect is associated with the assembly process.These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.Batch 8324556 is considered in compliance with our product specification requirements.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

• Brand Name: BD¿ LUER SLIP TIP SYRINGE GAMMA IRRADIATED (LOW DOSE), 10 ML
• 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 ; 8015296192
• MDR Report Key: 13636412
• Report Number: 1213809-2022-00106
• Device Sequence Number: 2226072
• Product Code: FMF
• UDI-Device Identifier: 50382903044066
• UDI-Public: 50382903044066
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2022

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: 304406
• Device Catalogue Number: 304406
• Device Lot Number: 8324556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2022
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2018
• 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