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

Catalog Number 306594

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2018

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: (b)(6) hospital.Results: investigation summary: a sample was received in the columbus plant for evaluation.It has no packaging flow wrap.The barrel label confirms the lot# 7115746.It has the tip.The plunger rod-rubber stopper are pushed all the way down.There is no saline solution.The plunger rod was visually inspected finding no damages.The barrel flange is damaged.Root cause could not be determined.This is the first complaint to the batch 7115746 for the same defect or symptom.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 for plunger rod broken/ damage documented during the production of this batch.Investigation conclusion there were no issues for plunger rod broken/ damage documented during the production of this batch.All our inspections performed while manufacturing this batch were accepted.No rejections were documented.Product was not within specification.Root cause description root cause could not be determined.

Event Description

It was reported that a nurse found the plungers broken on two bd 5ml posiflush¿ syringes prior to use.There no report of medical intervention.

• Brand Name: BD POSIFLUSH¿ PRE-FILLED SALINE 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: 7225853
• MDR Text Key: 98735956
• Report Number: 1911916-2018-00005
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K161552
• 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: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 306594
• Device Lot Number: 7115746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2017
• 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