MAUDE Adverse Event Report: COVIDIEN LP/LLC, NORFOLK UNKNOWN NEEDLE/SYRINGE; SYRINGE, PISTON

Model Number UNK NS

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 02/20/2018

Event Type  malfunction  

Manufacturer Narrative

Submit date: 4/11/2018.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.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reported several covidien monoject syringes found to be unusable while repacking morphine for intrathecal use.Plunger tip neither straight, nor secure in barrel causing concern for accuracy and integrity of finished preparation.The additional remark in the medwatch form of dust and debris inside the packaging and inside barrel of syringe, and excess lubricant on tip of plunger.

Manufacturer Narrative

Submitted date: 08/17/2018.An investigation was performed for the reported customer complaint: ¿the customer reported several covidien monoject syringes found to be unusable while repacking morphine for intrathecal use.Plunger tip neither straight, nor secure in barrel causing concern for accuracy and integrity of finished preparation.The additional remark in the medwatch form of dust and debris inside the packaging and inside barrel of syringe, and excess lubricant on tip of plunger.¿ a review of the device history record (dhr) for reported lot number 730512x indicates that product and specification requirements were met with no non-conforming product identified relating to this customer report.During the manufacturing of the syringe assemblies, syringes were visually inspected and physically tested.No deficiencies were recorded relating to this customer report.Control mechanisms are in place to prevent the occurrence and acceptance of damaged syringes during the syringe molding, assembly and packaging processes.These mechanisms include, but are not limited to: material verification/certification processes, periodic audits, dimensional specifications, machine maintenance requirements, and personnel training and certification.The syringe barrel is visually inspected periodically during the production process to the visual standards defined by the classification of defects in the quality inspection standard.A lot cannot be released unless it passes all visual and physical testing requirements.Inspectors routinely examine the product to ensure it meets acceptable quality level (aql) sampling criteria.Inspections focus on damaged product or components, holes, splits, or cracks in barrel which permit leakage, leakage in fluid pathway, and luer tip not to specification.Testing for this component during production includes the plunger being exercised during the assembly process to distribute the silicone in the barrel and on the rubber tip.Leak testing is also conducted to ensure the syringe draws, holds and expels fluid properly.The syringe is intended to be a single use syringe and not qualified as a prefill syringe.The actual device was returned for evaluation.The sample received was one (1) opened blister strip package identified with item code 1180100777, lot number 730512x.Included was the syringe sample.A complete investigation was performed.Visual inspection noted a small white inclusion embedded in the wall of the syringe barrel close to the graduation line.The syringe sample did not exceed acceptable quality limits.No other deficiencies were noted.The plunger rod and rubber tip were exercised inside of the syringe barrel with no evidence of wavy rubber tip and silicone presence was normal.Potential causes of inclusions in molded components could be a result of the degradation of white colorant during the molding process, degradation of resin during the molding process, or improper cleaning and maintenance of the molding tool.No production or inspection records indicated any of these scenarios occurred in relation to the reported event.The reported customer complaint is confirmed.A root cause could not be determined.At this time, there is not enough information to warrant the initiation of any further action.No corrective or preventive action is planned at this time.This complaint will be used for trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN NEEDLE/SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN LP/LLC, NORFOLK; 1222 sherwood rd; norfolk NE 68701 9062
• Manufacturer (Section G): COVIDIEN LP/LLC, NORFOLK; 1222 sherwood rd; norfolk NE 68701 9062
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7422488
• MDR Text Key: 105382304
• Report Number: 1915484-2018-00019
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 08/17/2018

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: Health Professional
• Device Model Number: UNK NS
• Device Catalogue Number: UNK NS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/20/2018
• Initial Date FDA Received: 04/11/2018
• Supplement Dates Manufacturer Received: 03/20/2018
• Supplement Dates FDA Received: 08/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1