MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE; PISTON SYRINGE

Catalog Number UNKNOWN

Device Problem Leak/Splash (1354)

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

Event Date 06/17/2022

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.Therefore, bd corporate headquarters in (b)(4) has been listed in manufacturer name, city and state and manufacturer site and the (b)(4) fda registration number has been used for the manufacture report number.Date of event is unknown.The date received by manufacturer has been used for this field.Medical device lot #: unknown.Medical 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.

Event Description

It was reported that leakage occurred while using an unspecified bd syringe.No patient impact reported.The following information was provided by the initial reporter: second microbore extension set used had primed with ease.Placed the hizentra medication syringe into the iv alaris pump.After starting the medication to infuse, noticed immediately leakage from the medication syringe tip and microbore extension set.Removed medication from the iv alaris pump and asked another colleague to help me assess the syringe and tubing.We removed the hizentra medication syringe and assessed for any cracks in the tip of the syringe.We then assessed the tubing and placed a 5 ml ns syringe onto the tip of the microbore extension set and immediately saw a leak on the side of the insertion site tip of the tubing.

Event Description

It was reported that leakage occurred while using an unspecified bd syringe.No patient impact reported.The following information was provided by the initial reporter: second microbore extension set used had primed with ease.Placed the hizentra medication syringe into the iv alaris pump.After starting the medication to infuse, noticed immediately leakage from the medication syringe tip and microbore extension set.Removed medication from the iv alaris pump and asked another colleague to help me assess the syringe and tubing.We removed the hizentra medication syringe and assessed for any cracks in the tip of the syringe.We then assessed the tubing and placed a 5 ml ns syringe onto the tip of the microbore extension set and immediately saw a leak on the side of the insertion site tip of the tubing.

Manufacturer Narrative

Investigation summary as no physical sample, valid part number or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.One picture sample was received for evaluation by the quality team.The pictures shows the end of a tube and a white line is visible at the end of the tube.A device history review could not be completed as no batch number was provided.Based on the limited investigation results, a cause for the reported incident could not be determined.

• Brand Name: UNSPECIFIED BD SYRINGE
• Type of Device: PISTON SYRINGE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15034064
• MDR Text Key: 303062509
• Report Number: 2243072-2022-00957
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• 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
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: No
• 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?: Yes
• Date Manufacturer Received: 07/22/2022
• 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