MAUDE Adverse Event Report: COVIDIEN 60ML SYRINGE LUER LOCK TIP; SYRINGE, PISTON

Model Number 1186000777

Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2020

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

As per the customer, a staff in oncology department had successfully drawn up the chemo drug herceptin for mixing and the syringe burst open through the barrel while injecting the chemo drug into the iv bag.The staff had used a 16-gauge needle with the syringe.The syringe was visually examined prior to use.The customer further stated that, six vials of herceptin was wasted during this mixing.The staff was behind a fume hood, was wearing appropriate gloves and gown.There was no injury, harmful direct skin exposure to the staff involved.

Manufacturer Narrative

The device history record was reviewed, and the shop orders indicate that product and specification requirements were met with no non-conforming product identified relating to this customer report.One unpackaged sample was returned for this customer report.A complete investigation was performed.A visual inspection to the quality inspection standard was conducted.The cracked syringe barrel was identified; the crack was approximately 3 ½¿ long running through the luer skirt, along the barrel face, and down the syringe barrel wall.The reported condition was confirmed.An exact root cause for the reported condition was not identified however some potential contributing factors for a cracked syringe can be a result of the following: user or machine technique as applicable during filling process.Impact from the needle insertion into medication port on iv bag.Unknown variables such as whether the medication was prefilled, length of time the medication was drawn into syringe, potential impact from the interaction of the medication (herceptin) with the syringe barrel component, and storage conditions prior to use.Not following the instructions for use; this syringe is intended to be a single use syringe and is not qualified as a prefill syringe.Brittleness due to raw material resin or molding operating conditions.All molding operating setup and materials are verified with each production lot and at prescribed intervals per procedure.Per procedure, all lots and shop orders are visually and physically inspected to the quality inspection standard and the statistical sampling must meet the acceptable quality limit requirements during the molding and assembly process.Complaint trends are evaluated during the monthly meeting to determine if a corrective/preventative action (capa) is warranted.At this time, there is no trending or information that would trigger the need to initiate a capa.

• Brand Name: 60ML SYRINGE LUER LOCK TIP
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 9700534
• MDR Text Key: 180399956
• Report Number: 1915484-2020-01127
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10884521010864
• UDI-Public: 10884521010864
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1186000777
• Device Catalogue Number: 1186000777
• Device Lot Number: 933647X
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/06/2020
• Patient Sequence Number: 1