MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 10 ML BD POSIFLUSH SP PRE-FILLED FLUSH SYRINGE NACL 0.9%

Catalog Number 306575

Device Problem Short Fill (1575)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/12/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: one sample was received for evaluation.It came in a (b)(4) plastic bag.It has no packaging flow wrap.The plunger rod- rubber stopper is at 3ml.The sample has solution up to the 3ml mark with tip cap.The photo provided shows the same sample was received for evaluation.The automated equipment leaves the plunger rod-rubber stopper at the 10ml position of the scale marking.It is at the 3ml position of the scale marking.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: 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.Root cause description: the reported symptom is confirmed.However, the sample received is not in its original packaging and not to our manufacturing process, therefore, the root cause is unknown.Rationale: capa not required at this time.

Event Description

It was reported that 10 ml bd posiflush¿ sp pre-filled flush syringe nacl 0.9% had less fill than design specifications.This was discovered before use.The following information was provided by the initial reporter: normal saline only 3cc.

• Brand Name: 10 ML BD POSIFLUSH SP PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10103081
• MDR Text Key: 199893609
• Report Number: 1911916-2020-00501
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 306575
• Device Lot Number: 9352483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other