MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 3ML SALINE 3ML FILL; SALINE, VASCULAR ACCESS FLUSH

Model Number	306544
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone #: (b)(6).Initial reporter facility name: (b)(6).Investigation summary: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of product malfunction during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that 5 syringe 3ml saline 3ml fill experienced difficult plunger movement.The following information was provided by the initial reporter: material no: 306544, batch no: unknown.Wcs manager is stating they can¿t use the new flushes because they are hard to flush and potential to blow iv lines for nicu babies.She says they have to use the longer skinny flush.Cno agreed and the compromise was we would only add back to that one floor.¿ along with there not being a smooth delivery of flush through the short 3 ml ns syringes, the short syringe is difficult to manage when you have a small appendage and 6 hands trying to hold, tape, and stabilize the iv, t-connector, clear cap, and syringe.The syringe is too bulky for ease of access to it or trying to keep it in position so that it doesn¿t pull on the tubing.We all encountered difficulties with both admits yesterday.Number of occurrences: 5.0.

• Brand Name: SYRINGE 3ML SALINE 3ML FILL
• Common Device Name: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 12054625
• Report Number: 1911916-2021-00587
• Device Sequence Number: 3592388
• Product Code: NGT
• UDI-Device Identifier: 30382903065449
• UDI-Public: 30382903065449
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 306544
• Device Catalogue Number: 306544
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1