MAUDE Adverse Event Report: COVIDIEN 1CC INS SAFETY SYR 30X5/16; SYRINGE, PISTON

Model Number 8881511310

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2020

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer stated that the needle became stuck in the medication vial rubber stopper and it was cleanly detached from the hub.There was no patient harm reported.

Manufacturer Narrative

Based on additional information provided by the initial reporter on 25-feb-2020 the following sections have been updated: section b5, describe event or problem: added "additional clarification from the customer on 25-feb-2020 stated that it was not a clean detachment; it broke off from the syringe.The customer further clarified that the pre-attached insulin needle bent and broke in the insulin vial while drawing up medication.".

Event Description

The customer reported that the needle broke off in a medication vial.The customer further stated that the needle became stuck in the medication vial rubber stopper and it was cleanly detached from the hub.There was no patient harm reported.Additional clarification from the customer on 25-feb-2020 stated that it was not a clean detachment; it broke off from the syringe.The customer further clarified that the pre-attached insulin needle bent and broke in the insulin vial while drawing up medication.

Manufacturer Narrative

The device history record of the reported lot # 912656x was reviewed and indicated that the product was released accomplishing all quality standards.The customer has provided a picture of the reported condition.In the picture, there is one safety syringe missing a cannula.The cannula can be seen in the blister package.Upon visual evaluation, the reported condition is confirmed.Per the customer, the sample was discarded.Without a representative sample(s) being provided, a more complete investigation cannot be performed.The breakage has been known to occur if needles become bent due to improper sheath removal, improper use or repeated use.Improper sheath removal and improper use can result in the needle being bent and compromising its strength.If the syringe is used multiple times the needle can fatigue and break at the end.Our syringes are designed to be single use and then disposed of.All lots of hypodermic needle tubing are statistically sampled and tested for needle stiffness and breakage per international standard iso 9626 stainless steel needle tubing for manufacture of medical devices.The assembly machine that this product is manufactured on is equipped with an adhesive detection station that verifies the presence of the adhesive and the needle, it contains a detect station that will reject product with bent or missing needles, and it checks the height of the needle.During manufacturing, the associates test the product for needle penetration to verify that the needle is not dull or damaged.The associates physically test the product for needle pull strength to verify that the adhesive is cured, and needles are secured to the barrel per specification requirements.As part of the inspection process, we perform a leak test of the syringe, which requires the associates to verify that the needle is affixed to the syringe.If problems were detected during manufacturing and testing, the non-conforming product would be rejected.During production, the processing equipment is checked regularly to verify that the detection systems are functioning properly.Per manufacturing plant procedure, complaint trends will be evaluated during the monthly corrective and preventive action (capa) meeting to determine if a capa is warranted.Based on the information available and the investigation findings, a capa is not deemed necessary at this time.

• Brand Name: 1CC INS SAFETY SYR 30X5/16
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 9662158
• MDR Text Key: 178336325
• Report Number: 1915484-2020-01126
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 20884521014999
• UDI-Public: 20884521014999
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8881511310
• Device Catalogue Number: 8881511310
• Device Lot Number: 912656X
• Date Manufacturer Received: 01/29/2020
• Patient Sequence Number: 1