MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ SLIP TIP SYRINGE

Catalog Number	304406
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2018
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 a box of bd¿ slip tip syringes arrived with bag label missing and liner bag missing.There was no report of exposure, serious injury, or medical intervention.
Additional Manufacturer Narrative
Investigation summary: three photos were received and evaluated.Two photos show a top view at an angle of an opened bulk non sterile box of 10ml bagged product.The 10ml assembled syringes can be seen inside a poly bag.A tip of a twist tie can be seen protruding from underneath the area where the bag is tied.It is not possible to tell from the photos provided whether there is 1 or 2 bags present.One photo shows a label on a box from batch #8143756 (p/n 304406).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.Please note, per procedure only 1 bag is twist tied, while the second bag is covered and may be twisted without a twist tie.The reported defect was not identified in the samples received.
Event or Problem Description
It was reported that a box of bd¿ slip tip syringes arrived with bag label missing and liner bag missing.There was no report of exposure, serious injury, or medical intervention.

• Brand Name: BD¿ SLIP TIP SYRINGE
• Common Device Name: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8066920
• Report Number: 1213809-2018-00798
• Device Sequence Number: 14000753
• Product Code: FMF
• UDI-Device Identifier: 50382903044066
• UDI-Public: 50382903044066
• Combination Product (Y/N): N
• Initial Reporter Country: DR
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2019

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 Catalogue Number: 304406
• Device Lot Number: 8143756
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 01/15/2019
• 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