MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH SP PRE-FILLED FLUSH SYRINGE NACL 0.9%; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306575

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

Patient Problem No Patient Involvement (2645)

Event Date 05/26/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: one photo was provided for evaluation.It shows two syringes.One sample has a bowed syringe barrel tip, and the other one is straight.It could have happened that the syringe was not correctly placed in the fixture when it was to be sterilized.Then, the fixture was placed on top, causing the damaged of the syringe barrel.The high sensor was challenged as a way to monitor its effectiveness.It passed.This is the 1st complaint for this defect or symptom.This lot was produced for 0.691mm units.This gives us a cpm of 1.4.We will continue monitoring and trending this lot for this symptom.We appreciate you taking the time to bring this observation to our attention.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Investigation conclusion: this is the 1st complaint for lot # 9352483 for this type of defect or symptom.There was no documentation for this type of defect during the entire production run of this batch.Root cause description: it could have happened that the syringe was not correctly placed in the fixture when it was to be sterilized.Then, the fixture was placed on top, causing the damaged of the syringe barrel.The high sensor was challenged as a way to monitor its effectiveness.It passed.Rationale: capa not required at this time.

Event Description

It was reported that 2 bd posiflush¿ sp pre-filled flush syringes nacl 0.9% had distorted barrels that were discovered prior to use.The following information was provided by the initial reporter: "distorted barrel".

Manufacturer Narrative

Correction: samples were received from the customer, and an updated investigation was performed: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 2020-06-25.Investigation: h.6.Investigation summary: one photo was provided for evaluation.It shows two syringes.One sample has a bowed syringe barrel tip, and the other one is straight.It could have happened that the syringe was not correctly placed in the fixture when it was to be sterilized.Then, the fixture was placed on top, causing the damaged of the syringe barrel.The high sensor was challenged as a way to monitor its effectiveness.It passed.This is the 1st complaint for this defect or symptom.This lot was produced for 0.691mm units.This gives us a cpm of 1.4.We will continue monitoring and trending this lot for this symptom.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Update 6/25/2020_ two samples were received.Both samples came in a ziploc plastic bag.They have no packaging flow wrap.Both have the syringe barrel luer bent.No other defect or issue was observed.Investigation conclusion: this is the 1st complaint for lot # 9352483 for this type of defect or symptom.There was no documentation for this type of defect during the entire production run of this batch.This lot was produced for 0.691mm units.With a cpm of 1.4.We will continue monitoring and trending this lot for this symptom.Update 6/25/2020_ two samples were received.Both samples came in a ziploc plastic bag.They have no packaging flow wrap.Both have the syringe barrel luer bent.No other defect or issue was observed.Root cause description: it could have happened that the syringe was not correctly placed in the fixture when it was to be sterilized.Then, the fixture was placed on top, causing the damaged of the syringe barrel.Rationale: capa not required at this time.H.6.Method codes: 10, 3331.H.6.Result codes: 114, 170.H.6.Conclusion codes: 23.

Event Description

It was reported that 2 bd posiflush¿ sp pre-filled flush syringes nacl 0.9% had distorted barrels that were discovered prior to use.The following information was provided by the initial reporter: "distorted barrel".

• Brand Name: BD POSIFLUSH SP PRE-FILLED FLUSH SYRINGE NACL 0.9%
• 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: 10170448
• MDR Text Key: 197174885
• Report Number: 1911916-2020-00556
• 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: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 306575
• Device Lot Number: 9352483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Date Manufacturer Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other