MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYR10ML LL W/NDL 18X1-1/2 BLUNT FILL; PISON SYRINGE

Catalog Number	305064
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2019
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 a piece of plastic was found inside of bd syr10ml ll w/ndl 18x1-1/2 blunt fill.Reported by customer: "we recently had a safety sos for an item that may have had some plastic in it.It was a 10ml luer syringe combo with blunt fill 18g x 1 ½¿ needle (305064), lot number 8266928.".
Event or Problem Description
It was reported that a piece of plastic was found inside of bd syr¿10ml ll w/ndl 18x1-1/2 blunt fill.Reported by customer: "we recently had a safety sos for an item that may have had some plastic in it.It was a 10ml luer syringe combo with blunt fill 18g x 1 ½¿ needle (305064), lot number 8266928.".
Additional Manufacturer Narrative
H.6.Investigation: three photos were received and evaluated.One photo displayed an open blister pack from batch #8266928 (p/n 305064).Two photos displayed a loose 10ml syringe with 7.5ml of clear fluid and a red tip cap.It was observed in the photos of the syringes, there was an anomaly present, but a determination could not be made for the origin or composition.It appeared it could have been a scratch on the barrel or a plastic fiber in the fluid path.The syringe in the photos was also been manipulated so the defect cannot be confirmed.Root cause not defined since defects were not confirmed in the photos received.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.

• Brand Name: BD SYR10ML LL W/NDL 18X1-1/2 BLUNT FILL
• Common Device Name: PISON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8421932
• Report Number: 1213809-2019-00336
• Device Sequence Number: 277779
• Product Code: FMF
• UDI-Device Identifier: 30382903050643
• UDI-Public: 30382903050643
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2019

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: 09/30/2023
• Device Catalogue Number: 305064
• Device Lot Number: 8266928
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 04/26/2019
• 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