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

Catalog Number 306595

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Investigation summary: samples were received for evaluation by one of our quality engineers.The samples have no packaging flow wrap.They all have the plunger rod-rubber stopper, the tip cap and saline solution.The barrel labels confirm the lot# 7250637.None of them have the plunger rod thumb press damaged, however, all of the samples have 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 7250637 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 conclusion: all our inspections and testing performed while manufacturing this batch were accepted.No rejections were documented.Update jun 26, 2018.Five (5) samples were received.Six (6) have no packaging flow wrap, they all have the plunger rod-rubber stopper, the tip cap and saline solution.The barrel labels confirm the lot# 7250637.All seven (7) have the barrel/flange damaged.None of them have the plunger rod thumb press damaged.Product within specification? yes / no.Root cause description: root cause could not be determined.There were no qns issued during the production of this batch listed in the complaint.All inspections and testing were accepted during the production of this batch.Root cause.The plunger rod labeler equipment possible experienced a variation; anyway, adjustments have been verified.Rationale: capa (b)(4) has been opened.

Event Description

It was reported that plunger rod of a 10 ml bd posiflush¿ normal saline syringe was broken, before use.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacturer: yes.

Event Description

It was reported that plunger rod of a 10 ml bd posiflush¿ normal saline syringe was broken, before use.There was no report of exposure, injury or medical intervention.

• Brand Name: 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7660561
• MDR Text Key: 113284662
• Report Number: 1911916-2018-00341
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: K982558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 08/17/2018

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: No Information
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 306595
• Device Lot Number: 7250637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Initial Date Manufacturer Received: 06/13/2018
• Initial Date FDA Received: 07/03/2018
• Supplement Dates Manufacturer Received: 06/13/2018
• Supplement Dates FDA Received: 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other