MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ SP SALINE SYRINGE; INTRAVASCULAR CATHETER

Catalog Number 306547

Device Problem Missing Information (4053)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/27/2022

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.

Event Description

It was reported that the bd posiflush¿ sp saline syringe had no scale markings.The following information was provided by the initial reporter: "one syringe had no marking at all.These items came like this in the package.".

Event Description

It was reported that the bd posiflush¿ sp saline syringe had no scale markings.The following information was provided by the initial reporter: "one syringe had no marking at all.These items came like this in the package.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 10-feb-2023.H6.Investigation summary: it was reported one syringe had no markings and the other came without a plunger.To aid in the investigation, three samples were received for evaluation by our quality team.Two samples came in sealed packaging flow wraps and one sample came with no packaging flow wrap.A visual inspection was performed.One sample has no syringe barrel label, one sample has no plunger rod and one sample has no defects or imperfections.No other defects or imperfections were observed.The missing plunger could occur if there was a jam during the plunger rod assembly process.A device history record review was completed for provided material number 306547, lot 2237674.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.The samples will be shown to associates for awareness.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.

Manufacturer Narrative

H6: investigation summary a device history record review was completed by our quality engineer team for provided material number 306547 and lot number 2237674.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.

Event Description

It was reported that the bd posiflush¿ sp saline syringe had no scale markings.The following information was provided by the initial reporter: "one syringe had no marking at all.These items came like this in the package".

• Brand Name: BD POSIFLUSH¿ SP SALINE SYRINGE
• Type of Device: INTRAVASCULAR CATHETER
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16237622
• MDR Text Key: 308921373
• Report Number: 1911916-2023-00026
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903065479
• UDI-Public: 00382903065479
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2023

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 Catalogue Number: 306547
• Device Lot Number: 2237674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2023
• Initial Date FDA Received: 01/24/2023
• Supplement Dates Manufacturer Received: 01/31/2023; 02/16/2023
• Supplement Dates FDA Received: 02/15/2023; 03/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2022
• 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