MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD INTEGRA SYRINGE

Catalog Number UNKNOWN

Device Problem Leak/Splash (1354)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/19/2019

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).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device evaluated by mfr: 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

Material no.: unknown, batch no.: unknown.It was reported that during use of the unspecified bd¿ integra syringe that during the injection the medication leaked onto his skin and when he removed the syringe there was no needle.The user took the syringe apart and saw the needle inside.The following information was provided by the initial reporter: called consumer on 2019-07-31 14:23:48: for additional information.Stated that he wanted to know how the integra syringe works.He said during the injection the medication leaked onto his skin and when he removed the syringe there was no needle.He took the syringe apart and saw the needle inside.No medical attention was needed.Consumer does not have product information or lot #, said he gave everything back to the pharmacist and the product was replaced.Occurrence date is unknown.Also refused to provide mailing address or any additional information.We received a voicemail on (b)(6) 2019 at 3:17pm (cst) regarding a consumer/direct user who thinks that the needle might have popped off and be stuck in his leg.He also stated he doesn't know if it retracted or not.

Manufacturer Narrative

H.6.Investigation summary: 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.A device history record review could not be performed as lot number was unknown.H3 other text : see section h.10.

Event Description

Material no.: unknown, batch no.: unknown.It was reported that during use of the unspecified bd¿ integra syringe that during the injection the medication leaked onto his skin and when he removed the syringe there was no needle.The user took the syringe apart and saw the needle inside.The following information was provided by the initial reporter: called consumer on 2019-07-31 14:23:48: for additional information.Stated that he wanted to know how the integra syringe works.He said during the injection the medication leaked onto his skin and when he removed the syringe there was no needle.He took the syringe apart and saw the needle inside.No medical attention was needed.Consumer does not have product information or lot #, said he gave everything back to the pharmacist and the product was replaced.Occurrence date is unknown.Also refused to provide mailing address or any additional information.We received a voicemail on friday 7/19/19 at 3:17pm (cst) regarding a consumer/direct user who thinks that the needle might have popped off and be stuck in his leg.He also stated he doesn't know if it retracted or not.

• Brand Name: UNSPECIFIED BD INTEGRA SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8855466
• MDR Text Key: 153886721
• Report Number: 2243072-2019-01575
• 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: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 08/02/2019
• Supplement Dates Manufacturer Received: 07/19/2019
• Supplement Dates FDA Received: 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other