MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYR 10 ML FIL SALINE SHORTLENGTH PLUNGER ROD; INTRAVASCULAR CATHETER

Catalog Number	306499
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: one sample was received.It came in a ziploc plastic bag.The plunger is not assembled to the syringe.The rubber stopper is in the syringe at 9.5 mark.It has no tip cap.It has 8ml of solution.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.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.Investigation conclusion: this is the 1st complaint for lot # 9018605 for this type of defect or symptom.There was no documentation for this type of defect during the entire production run of this batch.Root cause description: since this event is reported it happened when administering chemotherapy, no further analysis will be performed to protect the safety of our personnel.The syringe is designed to flush the iv lines by pushing the plunger rod down.Not designed to pull it up.Rationale: capa not required at this time.
Event or Problem Description
It was reported that the bd syr 10 ml fil saline short length plunger rod separated from the stopper during use.The following information was provided by the initial reporter: verbatim: i was administering chemo and i went to check blood return with the syringe and when i pulled back the plunger disconnected from the syringe.I know this has been a problem with syringes but the flush was still in tact (the water didn't fall out) but part of the plunger did.I saved it.There is actually no chemo in the syringe.This was just used on a patient who was receiving chemo.The defective product has been saved for evaluation.Please advise on the next steps and if you would like us to send you the product.¿.

• Brand Name: SYR 10 ML FIL SALINE SHORTLENGTH PLUNGER ROD
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 9723293
• Report Number: 1911916-2020-00168
• Device Sequence Number: 1212809
• Product Code: NGT
• UDI-Device Identifier: 00382903064991
• UDI-Public: 00382903064991
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K161552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/06/2020

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: 01/31/2022
• Device Catalogue Number: 306499
• Device Lot Number: 9018605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 02/18/2020
• 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