MAUDE Adverse Event Report: COVIDIEN 3ML S-R W/SPCL PLNGR; SYRINGE, PISTON

Model Number 8881513702

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.A review of maintenance records (both corrective and preventive) and calibration records were reviewed and there were no issues.All scheduled maintenance and calibration activities were completed.There were no related process or material changes related to the reported condition for this product.A review of the machine setup was conducted and there were no issues.A sampling of product was reviewed, and no damage was seen.There were five photos and six samples were returned for the evaluation.The photos and samples were visually inspected.No crack was seen in the photos or on the samples received.The reported condition of cracked syringes is not confirmed.The exact root cause of the crack could not be determined, because the reported condition could not be confirmed from the photos or samples provided.Prior to a lot¿s release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan.Inspectors routinely examine a statistical sample both physically and visually.Specifically, samples are checked for damage and contamination throughout the production of the lot.The lot met all defined acceptance requirements and was released.The investigation did not identify a systemic issue with the product or process and a specific root cause could not be identified.Based on the information available, a corrective and preventive action (capa) is not necessary at this time.If additional information or samples are received, the investigation will resume as needed.This information will be utilized for trending purposes to determine the need for corrective actions.

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 reported that the syringes have cracks.

• Brand Name: 3ML S-R W/SPCL PLNGR
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• Manufacturer (Section G): COVIDIEN; 2010 east international speedw; deland FL 32724
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 10033256
• MDR Text Key: 192452657
• Report Number: 1017768-2020-00826
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/28/2020

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
• Device Operator: No Information
• Device Model Number: 8881513702
• Device Catalogue Number: 8881513702
• Device Lot Number: 009033
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/23/2020
• Initial Date FDA Received: 05/07/2020
• Supplement Dates Manufacturer Received: 04/23/2020
• Supplement Dates FDA Received: 05/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1