MAUDE Adverse Event Report: COVIDIEN ANG WNG 21G BCS W/LUER ADPTR; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	8881225299
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported that their standard 21g butterfly needles were temporarily replaced with the monoject blood collection 21g x 3/4".With this particular model they have noticed it can come unsheathed very easily and may cause a needle stick.The customer stated that they pulled out a kit to do a blood draw on a patient and noticed the plastic that covered the needle pulled the sheath and safe tied the needle before they could do anything with it.They brought this issue to the charge nurse at the time and when they examined the product they felt this would be a very easy way for someone to accidentally poke themselves.The customer stated that no one was hurt by this product but they felt the need to report it before someone did.The customer also stated that the vacutainer attachment falls off from the needle / tubing.All product was pulled and will not be used.Additional information received from the initial reporter on 18-jan-2021 stated that when they went to pull off the clear plastic that covers the needle, it would engage the safety mechanism and the needle would disengage.They could manually push the needle back so that they were able to use the product but this posed a safety risk around the product.Also, the attachment with the gray rubber that protected the needle would fall off the tubing after being removed from the package enabling a break in sterile technique.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Two used and 28 new samples were received at the manufacturing site for evaluation.Upon evaluation of the samples, the reported issue could not be confirmed.There were no issues observed with the samples.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.

• Brand Name: ANG WNG 21G BCS W/LUER ADPTR
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11193284
• Report Number: 1282497-2021-09850
• Device Sequence Number: 3700812
• Product Code: FOZ
• UDI-Device Identifier: 10884521013353
• UDI-Public: 10884521013353
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2021

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
• Operator of Device: Health Professional
• Device Model Number: 8881225299
• Device Catalogue Number: 8881225299
• Device Lot Number: 182640265
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 04/13/2021
• Patient Sequence Number: 1