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

Catalog Number 306594

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 12/31/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that 3 bd posiflush¿ syringes had broken plunger rods inside their packaging units.The following information was provided by the initial reporter, translated from (b)(6) to english: "the plunger of prefilled syringe was damaged, which part was out of the barrel, and no shedding part was found in the package".

Manufacturer Narrative

Correction: the following field has been updated: b.5.Describe event or problem: it was reported that 3 bd posiflush¿ syringes had damaged barrel flanges.The following information was provided by the initial reporter, translated from chinese to english: "the plunger of prefilled syringe was damaged, which part was out of the barrel , and no shedding part was found in the package" per bd investigation: "to aid in the investigation, two photos were provided for evaluation by our quality team.The photo shows a syringe in its packaging flow wrap.The syringe barrel flange has damage and the plunger rod has no damages." investigation: h.6.Investigation summary: a device history record review was completed for provided material number 306594 and lot number 0141766.The review did not reveal any detected quality issues during the production process that could have contributed to this reported defect.To aid in the investigation, two photos were provided for evaluation by our quality team.The photo shows a syringe in its packaging flow wrap.The syringe barrel flange has damage and the plunger rod has no damages.The second photo is of a shelf box.Investigation conclusion: based on the investigation with the photo sample analysis the symptom reported by the customer is confirmed.Root cause description: it could be possible for this defect to occur during the plunger rod assembly process.It may have been that the infeed scroll was not properly aligned inducing the barrel flange damage.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.See section h.10.

Event Description

It was reported that 3 bd posiflush¿ syringes had damaged barrel flanges.The following information was provided by the initial reporter, translated from chinese to english: "the plunger of prefilled syringe was damaged, which part was out of the barrel , and no shedding part was found in the package" per bd investigation: "to aid in the investigation, two photos were provided for evaluation by our quality team.The photo shows a syringe in its packaging flow wrap.The syringe barrel flange has damage and the plunger rod has no damages.".

• 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
• MDR Report Key: 11211464
• MDR Text Key: 228490040
• Report Number: 1911916-2021-00048
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 306594
• Device Lot Number: 0141766
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/01/2021
• Initial Date FDA Received: 01/21/2021
• Supplement Dates Manufacturer Received: 01/22/2021
• Supplement Dates FDA Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1