MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31G 6MM S/C U-100 RELION; PISTON SYRINGE

Model Number 328519

Device Problem Packaging Problem (3007)

Patient Problem Needle Stick/Puncture (2462)

Event Date 03/16/2021

Event Type  Injury  

Manufacturer Narrative

Date of birth: unknown.The patient¿s age was used to determine a placeholder date.Medical device expiration date: na.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that syringe 1.0ml 31g 6mm s/c u-100 relion needle pieced shield and caused a needle stick injury.The following information was provided by the initial reporter: material no.328519 batch no.9210965.It was reported that needle was through the wall and stuck himself with the needle.Finger was very bruised and was tested for (b)(6).Verbatim: consumer reported needle stuck on the side of barrel of syringe.Stuck this consumer when he grabbed the packet.Went to the doctor.His doctor completed blood work on him for (b)(6) twice.Said the finger looked bruised.This complaint was received by email on 3-16-2020 as spam and not processed correctly on (b)(4).Customer stated he purchased the relion syringes 6mm 1cc and one of the syringes has a needle inbreed inside the wall itself the inside the wall and it stuck him on the joint of his finger and he went to the doctor this morning.Customer said they ran some test on him and he is waiting for his results.Informed the customer to please hold onto the product for possible retrieval by the supplier.Issued (b)(6) gift card.

Event Description

It was reported that syringe 1.0ml 31g 6mm s/c u-100 relion needle pieced shield and caused a needle stick injury.The following information was provided by the initial reporter: material no.328519 batch no.9210965.It was reported that needle was through the wall and stuck himself with the needle.Finger was very bruised and was tested for aids.Verbatim: consumer reported needle stuck on the side of barrel of syringe.Stuck this consumer when he grabbed the packet.Went to the doctor.His doctor completed blood work on him for aids twice.Said the finger looked bruised.This complaint was received by email on 3-16-2020 as spam and not processed correctly on cs0024318 customer stated he purchased the relion syringes 6mm 1cc and one of the syringes has a needle inbreed inside the wall itself the inside the wall and it stuck him on the joint of his finger and he went to the doctor this morning.Customer said they ran some test on him and he is waiting for his results.

Manufacturer Narrative

The following field was updated due to corrected information: b.5.Describe event or problem: it was reported that syringe 1.0ml 31g 6mm s/c u-100 relion needle pieced shield and caused a needle stick injury.The following information was provided by the initial reporter: material no.328519 batch no.9210965.It was reported that needle was through the wall and stuck himself with the needle.Finger was very bruised and was tested for aids.Verbatim: consumer reported needle stuck on the side of barrel of syringe.Stuck this consumer when he grabbed the packet.Went to the doctor.His doctor completed blood work on him for aids twice.Said the finger looked bruised.This complaint was received by email on 3-16-2020 as spam and not processed correctly on cs0024318 customer stated he purchased the relion syringes 6mm 1cc and one of the syringes has a needle inbreed inside the wall itself the inside the wall and it stuck him on the joint of his finger and he went to the doctor this morning.Customer said they ran some test on him and he is waiting for his results.The following fields were updated due to additional information: d.10.Device available for eval?: yes d.10.Returned to manufacturer on: 4/30/2021.H.6.Investigation: customer returned (1) 31gx6mm, 1ml insulin syringe with an opened polybag from lot# 9210965.It was reported that needle stuck on the side of barrel of syringe, stuck this consumer when he grabbed the packet, and finger looked bruised.The returned syringe was examined, and it was observed that a single cannula was adhered to the syringe barrel between the 30 and 40 unit scale marking.The exposed cannula adhered to the barrel could have led to a needle stick, and potentially caused harm/bruising.A review of the device history record was completed for batch# 9210965.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.H3 other text : see h.10.

Event Description

It was reported that syringe 1.0ml 31g 6mm s/c u-100 relion needle pieced shield and caused a needle stick injury.The following information was provided by the initial reporter: material no.328519, batch no.9210965.It was reported that needle was through the wall and stuck himself with the needle.Finger was very bruised and was tested for aids.Verbatim: consumer reported needle stuck on the side of barrel of syringe.Stuck this consumer when he grabbed the packet.Went to the doctor.His doctor completed blood work on him for aids twice.Said the finger looked bruised.This complaint was received by email on (b)(6) 2020 as spam and not processed correctly on cs0024318.Customer stated he purchased the relion syringes 6mm 1cc and one of the syringes has a needle inbreed inside the wall itself the inside the wall and it stuck him on the joint of his finger and he went to the doctor this morning.Customer said they ran some test on him and he is waiting for his results.Informed the customer to please hold onto the product for possible retrieval by the supplier.Issued $15 gift card.

Manufacturer Narrative

The following field was updated due to corrected information: h.1.Type of reportable events: serious injury.H.6.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# 9210965.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.

• Brand Name: SYRINGE 1.0ML 31G 6MM S/C U-100 RELION
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11619049
• MDR Text Key: 243941229
• Report Number: 1920898-2021-00381
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00681131138345
• UDI-Public: 00681131138345
• Combination Product (y/n): N
• PMA/PMN Number: K170386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 05/19/2021

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: Lay User/Patient
• Device Model Number: 328519
• Device Catalogue Number: 328519
• Device Lot Number: 9210965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Initial Date Manufacturer Received: 03/16/2020
• Initial Date FDA Received: 04/06/2021
• Supplement Dates Manufacturer Received: 04/14/2021; 05/19/2021
• Supplement Dates FDA Received: 04/20/2021; 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 88