MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED RELION SYRINGE; PISTON SYRINGE

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problems Hypersensitivity/Allergic reaction (1907); Swelling/ Edema (4577)

Event Date 05/16/2022

Event Type  Injury  

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).The date received by manufacturer has been used for this field.Medical device expiration date: unknown.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

It was reported that while using an unspecified relion syringe, the needle pulled out of hub and an allergic reaction occurred.The patient was taken to the vet and the injection site was examined and nothing was found.Later, a biopsy was performed and the vet recommenced x-rays and possible surgical removal if the broken needle was found.The following information was provided by the initial reporter: consumer stated, piece of needle broke off in her dogs neck when she was administering insulin.She took the dog to vet right away and injection site was examined by vet but nothing was found.No xrays were taken.Some days later, she started to notice bumps and then a lump in the area where needle broke.Took dog to vet a second time, and the vet did a biopsy to check for cancer.Over the months lump on neck got bigger and it was determined that it is not cancer.Her vet told her, the dog is having a "inflammatory response due to foreign substance under the skin".The doctor is recommending xrays and if a needle is found, surgery to remove it.

Event Description

It was reported that while using an unspecified relion syringe, the needle pulled out of hub and an allergic reaction occurred.The patient was taken to the vet and the injection site was examined and nothing was found.Later, a biopsy was performed and the vet recommenced x-rays and possible surgical removal if the broken needle was found.The following information was provided by the initial reporter: consumer stated, piece of needle broke off in her dogs neck when she was administering insulin.She took the dog to vet right away and injection site was examined by vet but nothing was found.No xrays were taken.Some days later, she started to notice bumps and then a lump in the area where needle broke.Took dog to vet a second time, and the vet did a biopsy to check for cancer.Over the months lump on neck got bigger and it was determined that it is not cancer.Her vet told her, the dog is having a "inflamatory response due to foreign substance under the skin".The doctor is recommending xrays and if a needle is found, surgery to remove it.

Manufacturer Narrative

H.6.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Unable to perform dhr check for breaks off during use due to unknown lot number.Unable to perform dhr check for harm skin irritation due to unknown lot number.H3 other text : see h.10.

• Brand Name: UNSPECIFIED RELION 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14659053
• MDR Text Key: 294855103
• Report Number: 2243072-2022-00798
• 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: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/13/2022
• 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): Required Intervention