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

Catalog Number 306575

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/30/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: a picture was received in the columbus plant for evaluation.It shows the syringe with the barrel label confirming the lot# 7079981.It has the plunger stopper and has the saline solution in it.It shows the flange damaged.Root cause could not be determined.All our inspections performed while manufacturing this batch were accepted; no rejections were documented.There were no quality notifications issued during the production of this batch listed in the complaint.Investigation conclusion: this is the second complaint to the batch 7079981 for the same defect or symptom.The first complaint was (b)(4).There was no documentation of issues for the complaint of batch 7079981 during this production run.Investigation comments: all our inspections performed while manufacturing this batch were accepted; no rejections were documented.On dec 11, 2017.A picture was received.It shows the syringe with the barrel label confirming the lot# 7079981.It has the plunger stopper, it has the solution saline in it.It shows the flange damaged.Root cause could not be determined.There were no qns issued during the production of this batch listed in the complaint.All inspections were accepted during the production of this batch.There were no issues documented about any type of damaged parts.Possible root cause could be a process variation at the plunger rod labeler equipment.Investigation comments: all our inspections performed while manufacturing this batch were accepted; no rejections were documented.On dec 11, 2017.A picture was received.It shows the syringe with the barrel label confirming the lot# 7079981.It has the plunger stopper, it has the solution saline in it.It shows the flange damaged.Capa not necessary.

Event Description

It was reported that the bd posiflush¿ sp syringe had broken flange wings when opening the packages.Found before use.No serious injury or medical intervention noted.

• 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: 7119798
• MDR Text Key: 95193326
• Report Number: 1911916-2017-00356
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/27/2017

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 306575
• Device Lot Number: 7079981
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2017
• Initial Date FDA Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2017
• 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