MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE INTEGRA 3ML W/NDL 23X1 RB

Model Number 305271

Device Problems Break (1069); Leak/Splash (1354); Failure to Deliver (2338)

Patient Problem No Patient Involvement (2645)

Event Date 08/06/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that syringe integra 3 ml w/ ndl 23 x 1 rb was damaged, but still operable.The following information was provided by the initial reporter: "it was reported that plunger is failing and medication is getting lost.Customer does not know how much medication he administered in his last three uses.Verbatim: from phone call on (b)(6) 2020 15:00:07: consumer stated, when taking injection, plunger snapped into pieces.Stated, medication wasted.Stated, does not want replacement and will not send in syringe he had issue with because he does not want his dna compromised? stated, he will send unused syringes in for evaluation.Cl lot: 9093628, catalog: 305271, samples available.Email received (b)(6) 2020 10:56:44 verbatim from email below: no adverse event.Plunger is failing and medication is getting lost.Customer doesn't know how much medication he was administered in his last three uses he does not feel comfortable sending back one of his used syringes, so i advised him to send back an unused syringe from the same lot which he is willing to provide.He would like to have a different syringe for replacement if possible.".

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.H3 other text : see h.10.

Event Description

It was reported that syringe integra 3ml w/ndl 23x1 rb was damaged, but still operable.The following information was provided by the initial reporter: "it was reported that plunger is failing and medication is getting lost.Customer does not know how much medication he administered in his last three uses.Verbatim: from phone call on (b)(6) 2020 15:00:07: consumer stated, when taking injection, plunger snapped into pieces.Stated, medication wasted.Stated, does not want replacement and will not send in syringe he had issue with because he does not want his dna compromised? stated, he will send unused syringes in for evaluation.Lot: 9093628.Catalog: 305271.Samples available.Email received (b)(6) 2020 10:56:44.Verbatim from email below: no adverse event plunger is failing and medication is getting lost customer doesn't know how much medication he was administered in his last three uses he does not feel comfortable sending back one of his used syringes, so i advised him to send back an unused syringe from the same lot which he is willing to provide.He would like to have a different syringe for replacement if possible.".

• Brand Name: SYRINGE INTEGRA 3ML W/NDL 23X1 RB
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10461229
• MDR Text Key: 206013147
• Report Number: 1213809-2020-00578
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30382903052715
• UDI-Public: 30382903052715
• Combination Product (y/n): N
• PMA/PMN Number: K011103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 305271
• Device Catalogue Number: 305271
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 08/06/2020
• Supplement Dates FDA Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other