MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 6MM 90 BX 450 MO; PISTON SYRINGE

Catalog Number 324908

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Local Reaction (2035); Skin Inflammation (2443); No Code Available (3191)

Event Date 09/08/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 the consumer used the syringe 1.0ml 6mm 90 bx 450 mo to inject medication, and had "red skin, itchiness", and "hardness underneath" the skin after the injection that felt about "3 inches or 6 inches".The consumer is reportedly allergic to silicone, in which medically graded silicone was explained to be in the needles.The consumer has contacted their pharmacist about the issue.They have also contacted their doctor, who believes the event to be a "histamine reaction", and plans on using "intersalinally".The consumer has used the needles for allergy medication in the past, but has never had this issue occur before.As a result of the event, the consumer has not taken their medication "for a week".The following information was provided by the initial reporter: consumer reported she has been using this syringes recently and she started to notice red skin, itchiness hard underneath after the injection.Sometime the hard feeling for about 3 inches or 6 inches.She is allergic to silicone.She has had face swollen with the c pak mask.She used to use the needles for allergy medicine long back, this has not occurred in the past.Now she has started using the (bpc-157) for tendon ligament.She will try to do the allergy test soon.She has not taken the medicine for a week.She has not contacted the doctor yet.She is planning on contacting the doctor.She has called her pharmacist in canada.Explained consumer we do use medically graded silicone in our needles.Advised to save the sample if re occurrence.She rotates the injection site.She uses the new needle for her injection.From phone call on 09/16/2019 10:12:31: followed up with a consumer, she contacted the doctor, they thing it could be histamine reaction.They are not sure if where that allergic reaction came from.They are planning on using "intersalinally".

Event Description

It was reported that the consumer used the syringe 1.0ml 6mm 90 bx 450 mo to inject medication, and had "red skin, itchiness", and "hardness underneath" the skin after the injection that felt about "3 inches or 6 inches".The consumer is reportedly allergic to silicone, in which medically graded silicone was explained to be in the needles.The consumer has contacted their pharmacist about the issue.They have also contacted their doctor, who believes the event to be a "histamine reaction", and plans on using "intersalinally".The consumer has used the needles for allergy medication in the past, but has never had this issue occur before.As a result of the event, the consumer has not taken their medication "for a week".The following information was provided by the initial reporter: consumer reported she has been using this syringes recently and she started to notice red skin, itchiness hard underneath after the injection.Sometime the hard feeling for about 3 inches or 6 inches.She is allergic to silicone.She has had face swollen with the c pak mask.She used to use the needles for allergy medicine long back, this has not occurred in the past.Now she has started using the (bpc-157) for tendon ligament.She will try to do the allergy test soon.She has not taken the medicine for a week.She has not contacted the doctor yet.She is planning on contacting the doctor.She has called her pharmacist in canada.Explained consumer we do use medically graded silicone in our needles.Advised to save the sample if re occurrence.She rotates the injection site.She uses the new needle for her injection.From phone call on 2019-09-16 10:12:31: followed up with a consumer, she contacted the doctor, they thing it could be hystamine reaction.They are not sure if where that allergic reaction came from.They are planning on using intersalinally.

Manufacturer Narrative

Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch # 8029636.All inspections and challenges were performed per the applicable operations qc specifications.There were three (3) notifications [(b)(4)] noted that did not pertain to the complaint.There was one (1) notification [(b)(4)] noted for bent cannula.

• Brand Name: SYRINGE 1.0ML 6MM 90 BX 450 MO
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9104271
• MDR Text Key: 162967569
• Report Number: 1920898-2019-01017
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903249084
• UDI-Public: 00382903249084
• Combination Product (y/n): N
• PMA/PMN Number: K170386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 324908
• Device Lot Number: 8029636
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention