MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE WITH BD PRECISIONGLIDE NEEDLE; SYRINGE WITH NEEDLE

Catalog Number	309632
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 foreign matter occurred with a bd syringe with bd precisionglide¿ needle.The following information was provided by the initial reporter, "it was reported that there was black material found on the syringe.Thought i¿d pass along a photo of a 5 ml bd syringe issue we found today.One of our npt¿s brought it to my attention to forward along.I can¿t tell what the black material is¿ink or rubber? but it¿s all over the interior and exterior of the syringe within the wrapper.".
Additional Manufacturer Narrative
Investigation: one photo and one 5ml syringe with needle in a fully sealed blister pack confirmed to be from batch #9057975 (p/n 309632) were received and evaluated.It was observed in the photo and the sample there was black foreign matter throughout the inside of the package and on the barrel.The foreign matter on the barrel extended from the flange to the tip and on the hub of the needle with some particles in the fluid path.It appeared to be grease and at least one particle in the fluid path was larger than level 2 in size, which is rejectable per product specification.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.Machine logs indicate repairs were made to components involving grease during the time this batch was manufactured.Potential root cause for the foreign matter defect is associated with the material handling process.
Event or Problem Description
It was reported that foreign matter occurred with a bd syringe with bd precisionglide¿ needle.The following information was provided by the initial reporter, "it was reported that there was black material found on the syringe.Thought i would pass along a photo of a 5 ml bd syringe issue we found today.One of our npt¿s brought it to my attention to forward along.I can¿t tell what the black material is, ink or rubber? but it¿s all over the interior and exterior of the syringe within the wrapper.".

• Brand Name: BD SYRINGE WITH BD 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: 8617493
• Report Number: 1213809-2019-00542
• Device Sequence Number: 13974763
• Product Code: FMF
• UDI-Device Identifier: 30382903096320
• UDI-Public: 30382903096320
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2019

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 Expiration Date: 02/29/2024
• Device Catalogue Number: 309632
• Device Lot Number: 9057975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Initial Date Received by Manufacturer: 04/30/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 05/30/2019
• 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