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

Catalog Number 306594

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Investigation: one (1) sample was received for evaluation by one of our quality engineers.It has no packaging flow wrap.It has the plunger rod-rubber stopper, no tip cap and 1.5ml of solution.The barrel label confirms the lot# 7184884.It has the barrel/flange damaged therefore failure mode is verified.It is possible that the plunger rod labeler equipment experienced a variation.Adjustments have been verified.A capa (corrective action preventive action) has been initiated to address this issue.A device history review was completed and there were no documented issues for the complaint of batch 7184884 during this production run.There were no quality notifications were issued during the production of this batch listed in the complaint.All inspections were accepted during the production of this batch.There was no issue documented about barrel/flange damaged.Investigation comments: all our inspections performed while manufacturing this batch were accepted; no rejections were documented.Update jun26, 2018.One (1) sample was received.It has no packaging flow wrap, it has the plunger rod-rubber stopper, no tip cap.1.5ml of solution.The barrel label confirms the lot# 7184884.It has the barrel/flange damaged.Product within specification? 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 was no issue documented about barrel/flange damaged / leakage.Root cause.The plunger rod labeler equipment possible experienced a variation; anyway, adjustments have been verified.Capa (b)(4) has been opened.

Event Description

It was reported that the flange of a bd posiflush¿ syringe was broken before use.There was no report of exposure, injury or medical intervention.

• Brand Name: BD POSIFLUSH¿ SYRINGE
• Type of Device: 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: 7648074
• MDR Text Key: 112863835
• Report Number: 1911916-2018-00337
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 306594
• Device Lot Number: 7184884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2017
• 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