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

Catalog Number	309643
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
It was reported that during use of the bd syringe with hypodermic needle precisionglide¿ there was an issue with foreign matter on the top of the syringe.
Event or Problem Description
It was reported that during use of the bd syringe with hypodermic needle precisionglide¿ there was an issue with foreign matter on the top of the syringe.
Additional Manufacturer Narrative
H.6.Investigation summary: three photos and one loose syringe were received and visually evaluated.Based on the photos, the syringe was manipulated prior to arriving for evaluation.Photos depict unidentified liquid residue inside the barrel in the fluid path and on the stopper along with foreign matter particulate.The sample received had its stopper in the bottom out position.Upon inspection of the syringe, foreign matter was observed in the fluid path between the stopper and the bottom of the barrel.The foreign matter was a large brown particle, larger than level 2 in size.The foreign matter was wet with unidentified liquid residue inside the barrel.No further evaluation could be performed due to potential risk associated with handling the sample.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.The potential root cause for the foreign matter defect cannot be determined based on photos and the sample provided.The sample was received manipulated, not in its original packaging.Therefore, based on the available information it is not possible to conclude the defect was caused by a manufacturing process.The defect could not be confirmed to have originated at the manufacturing plant.

• Brand Name: BD SYRINGE WITH HYPODERMIC NEEDLE PRECISIONGLIDE¿
• Common Device Name: CONVENTIONAL SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8203788
• Report Number: 1213809-2018-00935
• Device Sequence Number: 218235
• Product Code: FMF
• UDI-Device Identifier: 30382903096436
• UDI-Public: 30382903096436
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2019

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: 11/30/2022
• Device Catalogue Number: 309643
• Device Lot Number: 7335909
• Initial Date Received by Manufacturer: 12/10/2018
• Supplement Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 03/19/2019
• 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