MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS CANNULA INTERLINK LEVER LOCK; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	303370
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8323958.Medical device expiration date: 2021-11-30.Device manufacture date: 2019-01-08.Medical device lot #: 9052740.Medical device expiration date: 2022-02-28.Device manufacture date: 2019-03-28.Medical device lot #: 9170530.Medical device expiration date: 2022-06-30.Device manufacture date: 2019-09-04.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that cannula interlink lever lock had foreign matter on 5 occasions.The following information was provided by the initial reporter: this is a report about foreign matter in a package.According to the customer's report, a black fm was found in a package during inspection.
Event or Problem Description
It was reported that cannula interlink lever lock had foreign matter on 5 occasions.The following information was provided by the initial reporter: this is a report about foreign matter in a package.According to the customer's report, a black fm was found in a package during inspection.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 6/18/2021.H.6.Investigation: eleven photos and five lever lock assemblies (material 303370) were received in sealed blisterpaks.The samples were visually evaluated.-two samples were from batch 8323958.One package had a loose strand of foreign matter larger than level 3 in size that appeared to be hair.One sample had a small blue particle larger than level 3 in size loose in the package.The small blue particle was not able to be defined based on visual inspection and will be forwarded for fourier transform infrared spectroscopy (ftir) analysis.One sample was received from batch 9170530.There appeared to be a small particle larger than level 3 in size stuck in the sealing area.This particle was not able to be defined based on visual inspection and will be forwarded for fourier transform infrared spectroscopy analysis(ftir).-two samples were received from batch 9052740.One sample from had several loose dust particulates larger than level 3 in size present in the package.One sample had a black strand of foreign matter larger than level 3 in size embedded in the lever lock body.The embedded foreign matter appeared to be burnt plastic.Fourier transform infrared spectroscopy (ftir) analysis was completed on the material observed in the sealed blister packs.A small portion of each of these materials was removed from the samples and prepared for fourier transform infrared spectroscopy (ftir) spectral analysis.The spectral analysis shows that the blue material observed in the sealed blister from lot 8323958 is most likely a type of poly acrylate and the dark material observed in the sealed blister from lot 9170530 is most likely a type of polyurethane.Potential root cause for the embedded foreign matter defect is associated with the molding process.The embedded foreign matter is most likely degraded plastic.This occurs when the resin is exposed to prolonged high temperatures inside the molding machine, such as during start up.Potential root cause for the loose foreign matter defect is associated with the material handling process.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

• Brand Name: CANNULA INTERLINK LEVER LOCK
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 12027428
• Report Number: 1213809-2021-00435
• Device Sequence Number: 4543202
• Product Code: FPA
• UDI-Device Identifier: 00382903033706
• UDI-Public: 00382903033706
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K940697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2021

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: Other
• Device Catalogue Number: 303370
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1