MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 10ML SALINE FILL CE; PREFILLED SALINE SYRINGE

Catalog Number 306575

Device Problem Volume Accuracy Problem (1675)

Patient Problem No Patient Involvement (2645)

Event Date 06/18/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the syringe 10ml saline fill ce experienced missing scale markings which was noted prior to use.The following information was provided by the initial reporter: posiflush 10ml syringe observed to have no markings or product identification on it making it unusable.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 7/16/2020.H.6.Investigation: one sample was received and evaluated.It came in an opened packaging flow wrap.It has no syringe barrel label.The syringe barrel has no damages.Two photos were provided.They show a syringe out of the packaging flow wrap with a syringe with no barrel label.There is a sensor that is challenged at the beginning of each shift.When the machine stops and restarts again, it may have a missing barrel label and escaped; there are no additional controls to detect it.A device history review could not be completed as no batch number was provided.

Event Description

It was reported that the syringe 10ml saline fill ce experienced missing scale markings which was noted prior to use.The following information was provided by the initial reporter: posiflush 10ml syring observed to have no markings or product identification on it making it unusable.

• Brand Name: SYRINGE 10ML SALINE FILL CE
• Type of Device: PREFILLED SALINE SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 10247763
• MDR Text Key: 199135773
• Report Number: 1911916-2020-00632
• 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: 07/22/2020

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: 306575
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 07/08/2020
• Supplement Dates Manufacturer Received: 06/18/2020
• Supplement Dates FDA Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other