MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE

Catalog Number UNKNOWN

Device Problem Volume Accuracy Problem (1675)

Patient Problem Injury (2348)

Event Date 03/13/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.

Event Description

It was reported that an unspecified number of an unspecified bd syringe experienced syringe volumetric inaccuracy which was noted during use.It is also being cautiously reported that the volumetric inaccuracy led to a serious injury in the form of underdosage.It has not been specified whether any medical intervention including a bolus dosage, were received as a result.The following information was provided by the initial reporter: while aspirating the medication, the syringe draws air, so not the entire amount of medication can be aspirated.

Manufacturer Narrative

This complaint has been identified as a duplicate of mfr report #: 3002682307-2020-00095.This incident has already been captured therefore this complaint should be disregarded.

Event Description

It was reported that an unspecified number of an unspecified bd syringe experienced syringe volumetric inaccuracy which was noted during use.It is also being cautiously reported that the volumetric inaccuracy led to a serious injury in the form of underdosage.It has not been specified whether any medical intevention including a bolus dosage, were received as a result.The following information was provided by the initial reporter: while aspirating the medication, the syringe draws air, so not the entire amount of medication can be aspirated.

• Brand Name: UNSPECIFIED BD SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9918019
• MDR Text Key: 188328028
• Report Number: 2243072-2020-00553
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other