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

Catalog Number	309625
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.(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 foreign matter (described as ¿plastic shards¿) were found in multiple bd¿ slip tip syringe(s) with needle.There was no report of exposure, injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: 1100 sealed 1ml packaged syringes with needle were received in 11 sealed shelf cartons and confirmed to be from batch #7238743 (p/n 309625).The samples were visually evaluated.One of the shelf cartons had severe water damage to box exterior.Each shelf carton was opened and each syringe was removed from package to perform visual inspection of syringe.No foreign matter defects were found in any of the samples.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 reported defect was not identified in the samples received, therefore no root cause or corrective action could be determined.Investigation conclusion: unable to determine a root cause since no fm was found in the samples received.
Event or Problem Description
It was reported that foreign matter (described as ¿plastic shards¿) were found in multiple bd¿ slip tip syringe(s) with needle.There was no report of exposure, injury or medical intervention.
Additional Manufacturer Narrative
Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: device returned to manufacture: yes.
Event or Problem Description
It was reported that foreign matter (described as ¿plastic shards¿) were found in multiple bd slip tip syringe(s) with needle.There was no report of exposure, injury or medical intervention.

• Brand Name: BD¿ SLIP TIP SYRINGE WITH 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: 7554220
• Report Number: 1213809-2018-00319
• Device Sequence Number: 13521965
• Product Code: FMF
• UDI-Device Identifier: 30382903096252
• UDI-Public: 30382903096252
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 08/24/2018

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: 07/31/2022
• Device Catalogue Number: 309625
• Device Lot Number: 7238743
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 05/10/2018; 05/10/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 07/19/2018; 10/03/2018
• 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