MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 5ML LL W/NDL 20X1-1/2 RB; PISTON SYRINGE

Model Number	309635
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	07/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of birth: only the patient's age was provided therefore a default date of birth has been listed.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 an unspecified number of syringes 5 ml ll w/ndl 20x1-1/2 rb experienced leakage and exposure to mucosal membrane during use.The following information was provided by the initial reporter: material no.:309635, batch no.:9155519.There was a crack in the barrel of the syringe that caused the medication oxytocin which is considered hazardous to shoot out into the employee's eye.The employee was observed in the er and eyes were flushed with water and has had no other issues or tests.
Event or Problem Description
It was reported that an unspecified number of syringes 5ml ll w/ndl 20x1-1/2 rb experienced leakage and exposure to mucosal membrane during use.The following information was provided by the initial reporter: material no.: 309635, batch no.: 9155519.There was a crack in the barrel of the syringe that caused the medication oxytocin which is considered hazardous to shoot out into the employee's eye.The employee was observed in the er and eyes were flushed with water and has had no other issues or tests.
Additional Manufacturer Narrative
The following had been updated due to corrected information: b.6.Relevant tests/laboratory data: observed in er, eyes flushed with water.H.1.Type of reportable events: serious injury.H.6.Investigation: one contaminated sample was received.The sample was reported to contain a hazardous substance, which leaked.Therefore, the sample could not be handled and evaluated.No photos of the reported defect were provided for evaluation, therefore the defect could not be confirmed.Furthermore, 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.Since no photos displaying the reported condition were received and no samples that could be evaluated safely, a potential root cause could not be defined.Since no potential root cause was defined, corrective actions are not necessary.H3 other text : see h.10.

• Brand Name: SYRINGE 5ML LL W/NDL 20X1-1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10348358
• Report Number: 1213809-2020-00502
• Device Sequence Number: 2942031
• Product Code: FMF
• UDI-Device Identifier: 30382903096351
• UDI-Public: 30382903096351
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (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): 08/11/2020

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: 05/31/2024
• Device Model Number: 309635
• Device Catalogue Number: 309635
• Device Lot Number: 9155519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 08/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 29 YR