MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE/NEEDLE

Catalog Number UNKNOWN

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/16/2019

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.(b)(4).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 that a needle break occurred with a unspecified bd syringe.The following information was provided by the initial reporter."material no.: unknown batch no.: unknown.It was reported that the needle broke off into the patient during injection.The reported lot number 8020747 did not verify with the given item number 305270, so product information will be captured as unknown until verified.Per (b)(4) verbatim: consumer reported during his injection last night, the needle broke off in his rear.Stated first time using product; stated 1st time using retractable syringe; stated happened on (b)(6) 2019; stated on his way to see a surgeon; stated he will not send back syringe; stated he is concerned it "will magically disappear"; stated he is getting a lawyer if bills are not paid; stated he wants all of his medical bills paid.Stated no surgery has been scheduled because it just happened last night.Lot: 8020747, item: 305270, expiration date unknown." from phone call on (b)(6) 2019 15:05:41: consumer stated he went to his doctor's office, stated the needle broke off in his rear and the doctor was able to remove it in the office.Stated needle was discarded once removed.Stated no follow up necessary stated he was not in a position to verify lot and item#.Ok to call back tomorrow same time and he'll have information ready.".

Manufacturer Narrative

H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.

Event Description

It was reported that a needle break occurred with a unspecified bd syringe.The following information was provided by the initial reporter, "material no.: unknown batch no.: unknown.It was reported that the needle broke off into the patient during injection.The reported lot number 8020747 did not verify with the given item number 305270 so product information will be captured as unknown until verified.Per (b)(4) verbatim: consumer reported during his injection last night, the needle broke off in his rear.Stated first time using product, stated 1st time using retractable syringe, stated happened on (b)(6) 2019, stated on his way to see a surgeon, stated he will not send back syringe, stated he is concerned it "will magically disappear", stated he is getting a lawyer if bills are not paid, stated he wants all of his medical bills paid.Stated no surgery has been scheduled because it just happened last night.Lot: 8020747, item: 305270, expiration date unknown." from phone call on 2019-04-18 15:05:41: consumer stated he went to his doctors office stated the needle broke off in his rear and the doctor was able to remove it in the office.Stated needle was discarded once removed.Stated no follow up necessary.Stated he was not in a position to verify lot and item#.Ok to call back tomorrow same time and he'll have information ready.".

• Brand Name: UNSPECIFIED BD SYRINGE/NEEDLE
• Type of Device: SYRINGE/NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8591024
• MDR Text Key: 144544216
• Report Number: 2243072-2019-00876
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention