MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE RELION INSULIN SYRINGE; PISTON SYRINGE

Model Number	328506
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0139917 medical device expiration date: na device manufacture date: 2020-06-26 medical device lot #: unknown medical device expiration date: unknown device manufacture date: unknown a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that relion® insulin syringes experienced 2 cases of hub separation from the device and 1 case of the cannula piercing through the shield.Product defects were noted during use.The following information was provided by the initial reporter: consumer stated, he found 2 syringes in a sealed bag with the needle hub dispatched from the barrel.2 syringes affected.Lot: 0139917, catalog: 328506, date of event: unknown.Stated, he stuck the palm of his hand when removing a sealed bag from the box because a needle was sticking through the bag that was sticking through a shield.Did not seek medical.Stated, same product but lot and date of event unknown.
Additional Manufacturer Narrative
H.6.Investigation: customer returned two (2) loose 1ml insulin syringes.Consumer reported that needle hub separated from 2 syringes; also reported needle stick from syringe that had needle through shield.Both returned syringes were examined, and it was observed that both exhibited broken barrels.No defects regarding a cannula through shield were observed on the returned syringes.A review of the device history record was completed for batch # 0139917.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted for this complaint.Confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (broken barrel) unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure (cannula through shield) process summary: a dial transfers the correct number of syringes to a tube where they drop by gravity through the tube coming to rest on top of the polybag sealing jaws.The polybag is formed by web that is wrapped around a metal tube where the sides of the web overlap and are sealed to form the vertical seal.Sealing jaws form the polybag bottom, as well as the top of the previous polybag.Between the sealing jaws is a knife that severs the bag from the roll.There were no quality notification or maintenance dispatches created for this issue during the production of this batch.Root cause cannot be determined.
Event or Problem Description
It was reported that relion® insulin syringes experienced 2 cases of hub separation from the device and 1 case of the cannula piercing through the shield.Product defects were noted during use.The following information was provided by the initial reporter: consumer stated, he found 2 syringes in a sealed bag with the needle hub dispatched from the barrel.2 syringes affected.Lot: 0139917, catalog: 328506, date of event: unknown, stated, he stuck the palm of his hand when removing a sealed bag from the box because a needle was sticking through the bag that was sticking through a shield.Did not seek medical.Stated, same product but lot and date of event unknown.

• Brand Name: RELION INSULIN SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10751773
• Report Number: 1920898-2020-01487
• Device Sequence Number: 1088370
• Product Code: FMF
• UDI-Device Identifier: 00681131311748
• UDI-Public: 00681131311748
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K170386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020

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
• Operator of Device: Lay User/Patient
• Device Model Number: 328506
• Device Catalogue Number: 328506
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Initial Date Received by Manufacturer: 10/07/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1