MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED SYRINGE

Catalog Number UNKNOWN

Device Problems Bent (1059); Aspiration Issue (2883); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2018

Event Type  malfunction  

Manufacturer Narrative

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.Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.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 during use of an unspecified syringe when preparing the patient medication, the syringe did not aspirate properly.The user noticed a defect in the syringe body with scratches and a bowed barrel.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation results: the batch history analysis (dhr) was not performed because the catalog number was unknown.Nor was it possible to check maintenance records and quality notifications.No photos or samples were returned by the client for evaluation.It was not possible to carry out an investigation and to determine the root cause for the defect.The production processes are validated according to the defined acceptance criteria.In this way it is not possible to confirm the claim.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Based on the severity, occurrence and quality data analysis for this product family a capa is not necessary.

• Brand Name: UNSPECIFIED SYRINGE
• Type of Device: UNSPECIFIED
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7280513
• MDR Text Key: 100563291
• Report Number: 2243072-2018-00055
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/01/2018
• Initial Date FDA Received: 02/19/2018
• Supplement Dates Manufacturer Received: 02/01/2018
• Supplement Dates FDA Received: 02/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other