MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 10 ML BD POSIFLUSH¿ SP SYRINGE

Catalog Number 306575

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 Description

It was reported that a 10 ml bd posiflush¿ sp syringe had a difficult plunger.The patient was unable to depress the plunger past the 4 ml mark.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

A sample was available and returned to bd for evaluation.A quality engineer was able to inspect the sample and found that the stopper mark was at the 3ml mark.It took 13.75n of force to push the plunger down and the specified pressure was less than 20n.The force necessary to compress the plunger was within the acceptable range and the reported issue could not be verified.The syringe was found to be in specification and no corrective actions were deemed necessary at this time.It was found that there was an issue with dry barrels at the fill room and that testing was being performed on the syringes.This was an isolated event and within the aql for the production run.Dhr review found that there was an issue with dry barrels at the fill room and that testing was being performed on the syringes.Ism performed a (b)(4) aql on the stack building checking (b)(4) accept on 0 reject on 1 and found 0.All our inspections performed while manufacturing this batch were accepted.There were no qns issued during the production of this batch listed in the complaint.Forty-seven representative samples were also sent to bd for evaluation.The samples were investigated and all of them were found to be within specification for plunger force.The highest reading was found to be 14.85n and the lowest was 7.85n.Capa not required for this event.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.

• Brand Name: 10 ML BD POSIFLUSH¿ SP SYRINGE
• Type of Device: FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7429452
• MDR Text Key: 105679671
• Report Number: 1911916-2018-00149
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 306575
• Device Lot Number: 7317951
• Date Manufacturer Received: 03/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other