MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE

Catalog Number UNKNOWN

Device Problem Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/28/2019

Event Type  malfunction  

Manufacturer Narrative

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.(b)(4).Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, catalog, or batch number were provided.Investigation conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided.This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences.Rationale: no sample, lot, or batch provided.

Event Description

It was reported that unspecified bd¿ syringe plunger was difficult to move.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no.Unknown batch no.Unknown it was reported there was plunger movement difficulty.(2 of 2 complaints): crm intake notes: description of issue: customer reported that insulin is not coming out of the syringe and needle (while not inserted into fill port of cartridge.Customer stated she tried pressing down on the plunger with more force, but it still does not move not release any insulin.Did the customer insert the needle into the cartridge and encounter fill resistance? no.Proceed to step 3.Number of occurrences: 1.Item number: choose one: 26 g, 3/8¿ needle ¿ 305110.Product lot number: 8284970.Are samples available for investigation? yes.Does customer authorize bd to contact customer to obtain sample(s)? yes contact: (b)(6).Did issue cause any injury? if yes, what type of injury? no.Medical intervention needed? if yes, who was the 3rd party and what was the assistance/treatment? no.Resolution: cts explained that bd might follow up with customer regarding returning syringe/needle.No further tandem follow up is required.Cts to goodwill replacement so customer does not run low.Note: product category = needle/syringe issue".

• Brand Name: UNSPECIFIED BD SYRINGE
• Type of Device: 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8556959
• MDR Text Key: 148418775
• Report Number: 2243072-2019-00805
• 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: distributor,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• 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?: Yes
• Date Manufacturer Received: 04/12/2019
• 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
• Patient Age: 69