MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ SP SYRINGE; SALINE FLUSH

Catalog Number 306575

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2018

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone#: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported before use of the bd posiflush¿ sp syringe there is difficulty in plunger movement.The customer stated ¿the user was unable to aspirate or push solution off syringe.¿ there was no report of injury or further medical intervention.

Manufacturer Narrative

A sample was received.It has no packaging flow wrap, and no tip cap; it has the plunger rod-rubber stopper, the solution is up to 5.5 ml mark scale.It was tested for sustaining force giving 21.75n, the spec is less than 20n therefore failure mode is verified.Dhr/bhr review during this batch dry barrels were found in the fill room.Ism performed a 0.04% aql on the stack building checking 315 accept on 0 reject on 1 and found 0.All inspections were accepted during the production of this batch.There was an issue with dry barrels at the fillroom; stat sampling was performed and pass; possible this is an escape from that incident.All our inspections performed while manufacturing this batch were accepted; there was an incident reported at the fillroom for dry barrels; stat sampling was performed and pass.Based on the samples received from other complaints and same batch, we can confirm the problem.

• Brand Name: BD POSIFLUSH¿ SP SYRINGE
• Type of Device: SALINE FLUSH
• 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 ; 8015652845
• MDR Report Key: 7412962
• MDR Text Key: 105276246
• Report Number: 1911916-2018-00159
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K003553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 306575
• Device Lot Number: 7317951
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2017
• 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