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

Catalog Number	306559
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Fda notified: the initial reporter also notified the fda (b)(4).Investigation summary: as no samples or pictures were received for evaluation, our quality team was unable to confirm the reported defect of pump incompatibility.As no lot number was provided, a device history record review could not be completed.It is important to note that the bd franklin flush syringe (product code 306500) does not claim pump compatibility.Bd does not recommend use of this product with a pump.The current controls for syringes including incoming, in-process, and final inspections will remain in place.Investigation conclusion: complaint: pump occlusion and plunger movement difficult.No sample received.A dhr could not be performed as no lot # was provided.There have been zero prior compalints for plunger movement difficult in the past year.There have been similar complaints for "pump alarm/occlusion/incompatibility" within the past year.Note: the bd franklin flush syringe does not claim pump compatibility.Bd does not recommend use of this product with a pump.Bd was not able to duplicate or confirm the customer's indicated failure mode.The customer's indicated failure mode of pump alarm/occlusion and plunger movement could not be confirmed as no sample or photo was provided.Based on the investigation, root cause was not found.No formal corrective action is required at this time.The current controls for syringes including incoming, in-process and final inspections will remain in place.Root cause description based on the investigation, root cause was not found.
Event or Problem Description
It was reported that during use a bd ¿ pre-filled normal saline syringe malfunctioned as " the medfusion syringe pumps are having trouble recognizing the loml bd pre- filled flushes.The pump will read "invalid syringe size" and reseating the flush does not work.The change in the plunger when posiflush came out caused increased drag and thereby increased pressure upon deployment of the fluid." there was no report of exposure, injury or medical intervention needed.

• 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: 7583730
• Report Number: 1911916-2018-00318
• Device Sequence Number: 18876590
• Product Code: FMF
• UDI-Device Identifier: 30382903065593
• UDI-Public: 30382903065593
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/08/2018

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: Nurse
• Device Catalogue Number: 306559
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 06/08/2018
• 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