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

Catalog Number	309569
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 10-15 syringes of the bd luer-lok syringe precisionglide needle bd syringe detachable precisionglide needle were either missing from packaging, or were breaking during use, and not locking into the barrel.Found during use.No reports of serious injury or medical intervention noted.
Additional Manufacturer Narrative
H.6.Investigation summary: no samples displaying the condition reported are available for examination.We were unable to fully investigate this incident.Lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Investigation conclusion: no root cause can be determined as no samples were received.

• Brand Name: BD LUER-LOK SYRINGE PRECISIONGLIDE NEEDLE DETACHABLE PRECISIONGLIDE NEEDLE
• Common Device Name: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7602408
• Report Number: 1213809-2018-00362
• Device Sequence Number: 11201181
• Product Code: FMF
• UDI-Device Identifier: 00382903095698
• UDI-Public: 00382903095698
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2018

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: 309569
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 06/26/2018
• 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