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

Catalog Number 306594

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: a device history record review was completed for provided material number 306594 and lot number 0058984.The review did not reveal any detected quality issues during the production process that could have contributed to these reported defects.To aid in the investigation, four photos were received for evaluation by our quality team.Photos one and four show a plunger rod and rubber stopper in an opened packaging blister.Photos two and three show a syringe barrel flange damaged.The syringe has no packaging flow wrap, but has solution and the plunger rod rubber stopper.It could be possible for the barrel flange damage to occur during the assembly process.A jam may have occurred inducing the damage and then was not detected during the next processes.Based on the investigation with the photo analysis for the barrel flange damage, the symptom reported by the customer is confirmed.For the other defect, the photos show a plunger rod with the rubber stopper.The packaging flow wrap has been opened and the product compromised.During the manufacturing process the rubber stopper is assembled into the barrel after the filling process.At the end of the final assembly the plunger rod is assembled to the syringe.The barrel has on the inside a retaining ring to prevent the plunger from falling out of the syringe.After the plunger rod assembly, the syringe is held by the barrel, not by the plunger rod, so the single plunger rod cannot be transferred to the packaging area.This process is automated with vision systems.The first and fourth photos received are not representative of our manufacturing process.Based on the investigation results for the other defect, the symptom by the customer could not be confirmed and an exact cause for this incident could not be identified.Investigation conclusion: barrel flange damaged: based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed.Other: based on the investigation and with the photo sample analysis the symptom reported by the customer could not be confirmed.The photos show a plunger rod with the rubber stopper.The packaging flow wrap has been opened and the product compromised.This is not representative of our manufacturing process.Root cause description: probable root cause for barrel flange damaged: a jam may have occurred at the plunger rod assembly machine inducing the barrel flange damaged and not detected in the next processes.Probable root cause for other: an exact cause for this incident could not be identified.Rationale: further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that 2 bd posiflush" syringes had damaged barrels.The following information was provided by the initial reporter, translated from (b)(6) to english: "there are only two plunger rods in this batch of products, and two flush's barrel are damaged.".

• Brand Name: BD POSIFLUSH SYRINGE
• Type of Device: SALINE VASCULAR ACCESS 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 ; 8015296192
• MDR Report Key: 11129097
• MDR Text Key: 229828083
• Report Number: 1911916-2021-00004
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 306594
• Device Lot Number: 0058984
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2020
• 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