MAUDE Adverse Event Report: COVIDIEN 20ML SYR LUER LOCK TIP RP; SYRINGE, PISTON

Model Number 8881520657

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problems Irritation (1941); Numbness (2415)

Event Date 03/11/2019

Event Type  Injury  

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 states when assisting with a scalene nerve block, the 20 cc syringe broke during injection.The rn was sprayed with local anesthetic (ropivacaine) in the face (eyes and mouth).The syringe was examined and multiple cracks, a broken tip, and a break in the collar around the tip was noticed.The rn rinsed her eye out at the eyewash station and had slight numbness to her lips for about 10-15 minutes after the incident.No further testing or intervention was required.

Manufacturer Narrative

One packaged and one unpackaged syringe was received for evaluation.A visual inspection determined that there were no issues found on the packaged product sample.The visual inspection of the unpackaged syringe identified that both the luer tip and a portion of the luer skirt were broken from the syringe barrel.It was also noted that the syringe had multiple cracks on the face and wall of the syringe.The reported condition of a broken luer tip and skirt was confirmed.A device history record (dhr) review of the reported lot no.902816x confirmed that the product was produced accomplishing quality requirements and released according to established procedures.An exact root cause for the reported condition was not identified but may occur during use if there were excessive force applied to the luer tip or if the syringe was used multiple times which would result in the weakening of the luer lock tip resulting in a broken syringe.Per procedure, 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: 20ML SYR LUER LOCK TIP RP
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 8433820
• MDR Text Key: 139238297
• Report Number: 1915484-2019-01029
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8881520657
• Device Catalogue Number: 8881520657
• Device Lot Number: 902816X
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/11/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other