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

Catalog Number UNKNOWN

Device Problem Failure to Prime (1492)

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

Event Date 09/19/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and/or 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 franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.6.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no capa/sa is required at this time.

Event Description

It was reported that 20 of the unspecified bd ¿ syringe were unable to prime.The following was translated from german to english: my customer (b)(6) reports that up to 20 needles "did not work" in the last packages of the above needles delivered to her.Unfortunately, she did not keep the needles or the package.When asked what the problem was, she explained: i always try the needles first.I put the new needle on the pen (kwikpen and flexpen) and set 2 units.Then i hold a tempo and check whether fluid is released after the pen is triggered.With the last delivery (3 packs), there was often no liquid visible in the tempo.This must mean that the needles are not permeable.

Manufacturer Narrative

Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no capa/sa is required at this time.

Event Description

It was reported that 20 of the unspecified bd ¿ syringe were unable to prime.The following was translated from german to english: my customer mrs c.O.Reports that up to 20 needles "did not work" in the last packages of the above needles delivered to her.Unfortunately, she did not keep the needles or the package.When asked what the problem was, she explained: i always try the needles first.I put the new needle on the pen (kwikpen and flexpen) and set 2 units.Then i hold a tempo and check whether fluid is released after the pen is triggered.With the last delivery (3 packs), there was often no liquid visible in the tempo.This must mean that the needles are not permeable.

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17865822
• MDR Text Key: 324877242
• Report Number: 2243072-2023-01781
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• 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: 10/05/2023
• 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