MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE; PISTON SYRINGE

Catalog Number	309572
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd syringe luer-lok¿ tip with bd precisionglide¿ needle had a cracked barrel that was noticed before use.The following information was provided by the initial reporter: "distributor called to report that customer has found a couple of syringes with cracks in the barrels.Stated that the customer was unsure of with lot number it came from, either 9008974 or 8300795".
Additional Manufacturer Narrative
Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.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.
Event or Problem Description
It was reported that the bd syringe luer-lok¿ tip with bd precisionglide¿ needle had a cracked barrel that was noticed before use.The following information was provided by the initial reporter: "distributor called to report that customer has found a couple of syringes with cracks in the barrels.Stated that the customer was unsure of with lot number it came from, either 9008974 or 8300795".

• Brand Name: BD SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8484919
• Report Number: 1213809-2019-00410
• Device Sequence Number: 1576618
• Product Code: FMF
• UDI-Device Identifier: 30382903095729
• UDI-Public: 30382903095729
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 309572
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 05/09/2019
• 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