MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD SLIP TIP SYRINGE; PISTON SYRINGE

Catalog Number	302833
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/05/2019
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 foreign matter was found in 10 bd¿ slip tip syringe barrels after opening their unit packaging.The following information was provided by the initial reporter, translated from (b)(6) to english: "after opening the unit package, it was found that foreign matter in barrel".
Event or Problem Description
It was reported that foreign matter was found in 10 bd¿ slip tip syringe barrels after opening their unit packaging.The following information was provided by the initial reporter, translated from chinese to english: "after opening the unit package, it was found that foreign matter in barrel".
Additional Manufacturer Narrative
Investigation: one (1) photo was provided by the customer for investigation.The photo shows a syringe removed from the blister pack which has brown spots on barrel.Based on the photo it cannot be determined if the brown spots are loose or embedded.Without a physical sample to analyze the foreign matter (fm) that appears to be on the barrel cannot be identified; therefore, potential root causes cannot be determined.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.

• Brand Name: BD SLIP TIP SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8629078
• Report Number: 1911916-2019-00506
• Device Sequence Number: 16608905
• Product Code: FMF
• UDI-Device Identifier: 30382903028338
• UDI-Public: 30382903028338
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2019

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: 07/31/2022
• Device Catalogue Number: 302833
• Device Lot Number: 7179512
• Initial Date Received by Manufacturer: 05/05/2019
• Supplement Date Received by Manufacturer: 05/05/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 06/03/2019
• 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