MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 3 ML BD SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE 25 G X 1 INCH; SYRINGE WITH NEEDLE

Catalog Number	309581
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/23/2017
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 after use of the 3 ml bd syringe with bd precisionglide¿ needle 25 g x 1 inch the needle was slightly bent and the hub was coming off the syringe.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
Results: bd received one sample from the customer facility for investigation.The sample was evaluated and a bent cannula was observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.A manufacturing review revealed no abnormalities with preventative maintenance, calibration, or equipment that could have influenced the customer's reported issue.Although bd was able to observe a bent cannula, an absolute root cause could not be determined for a cannula/hub separation.There are several root causes which could include assembly line has a 100% automated vision system that has the capability to detect clogged cannula.Cannula must be straight to pass clogged cannula vision test, or else it will automatically be rejected.Bent cannula will automatically be rejected in the production line.Bent cannula has an angularity of 7.92 degrees, shield will not be able to install on the assemble needle at shield loading station.In conclusion, bent needle will be rejected during assembly process by automated vision systems and will not go out of manufacturing facility.Non-conformance could have occurred out of manufacturing facility.

• Brand Name: 3 ML BD SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE 25 G X 1 INCH
• Common Device Name: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 6977563
• Report Number: 8041187-2017-00142
• Device Sequence Number: 19003817
• Product Code: FMF
• UDI-Device Identifier: 30382903057833
• UDI-Public: 30382903057833
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/28/2017

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: 04/30/2021
• Device Catalogue Number: 309581
• Device Lot Number: 6106416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Initial Date Received by Manufacturer: 10/04/2017
• Supplement Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 10/25/2017
• Supplement Report FDA Received Date: 01/02/2018
• 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