MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PRE-FILLED NORMAL SALINE SYRINGE

Catalog Number	306559
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial reporter also notified the fda on (03/20/2019) via medwatch # (b)(4).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 during use of the bd ¿ pre-filled normal saline syringe was leaking out of the distal "plunger" end of the syringe.The following information was provided by the initial reporter: material no.306559, batch.8261703."nurse went to flush a peripheral iv line, and found that the posiflush saline syringe was leaking out of the distal "plunger" end of the syringe.*this leaking could result in additional staff exposure to hazardous drugs.This event was originally reported on (b)(6) 2019, and was reported a second time on (b)(6) 2019.Lot # 8261703.What was the original intended procedure? flushing of iv.Device malfunction - that is, the device did not do what it was supposed to do.".
Additional Manufacturer Narrative
H.6.Investigation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified and the root cause could not be determined.A device history record review found no non-conformances associated with this issue during production of this batch.
Event or Problem Description
It was reported that during use of the bd ¿ pre-filled normal saline syringe was leaking out of the distal "plunger" end of the syringe.The following information was provided by the initial reporter: material no.306559 batch.8261703 "nurse went to flush a peripheral iv line, and found that the posiflush saline syringe was leaking out of the distal "plunger" end of the syringe.*this leaking could result in additional staff exposure to hazardous drugs.This event was originally reported on (b)(6) 2019, and was reported a second time on (b)(6) 2019.Lot # 8261703 what was the original intended procedure? flushing of iv device malfunction - that is, the device did not do what it was supposed to do;.".

• Brand Name: BD PRE-FILLED NORMAL SALINE SYRINGE
• Common Device Name: SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8496157
• Report Number: 1911916-2019-00364
• Device Sequence Number: 11462580
• Product Code: FMF
• UDI-Device Identifier: 30382903065593
• UDI-Public: 30382903065593
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K141311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2019

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: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 306559
• Device Lot Number: 8261703
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 04/09/2019
• Supplement Report FDA Received Date: 04/22/2019
• 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