MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD THREADED LOCK CANNULA; INTRAVASCULAR ADMINISTRATION SET

Model Number	303369
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9340415, medical device expiration date: 2024-11-30, device manufacture date: 2020-01-28.Medical device lot #: 9340416, medical device expiration date: 2024-11-30, device manufacture date: 2020-02-18.
Event or Problem Description
It was reported that 5 bd threaded lock cannula were damaged, but still operable.The following information was provided by the initial reporter: "the customer reported: some cannulas were found to be short.The customer is requesting for replacement by another lot products.".
Additional Manufacturer Narrative
H.6.Investigation: multiple photos and approximately 531 samples were received.The photos and physical samples represented product from two batches #9340415 and 9340416 (p/n 303369).298 samples were received from batch #9340416 in three 100-count cartons, 228 from batch #9340415 with 198 in two 100-count cartons and 30 in blister packs in a plastic bag.Also 5 unknown loose decontaminated samples were received.The short cannula defect was confirmed in the 5 loose decontaminated samples from cavity 13 and 43.Based on the customer photos there is a short cannula or possible damage to the cannula in five units.Three units in one of the images appear to have a short cannula and no signs of damage.Of the two units in another image one unit appears to have a short cannula and the other appears to have a damaged cannula.The short undamaged cannulas are most likely a result of a hot core pin.When the core pin is too hot it may pull the cannula as it is being retracted at the end of the molding cycle and prior to ejection.During the molding process operators perform visual inspections and maintenance per the sampling plan.A pm (preventative maintenance) is required after 21 days of running the equipment.Each production run is about 7 days.With infrequent runs, pm may end up being as long as 2 years apart.Idle time is likely to allow a build-up in the cooling channel of the core pin, thereby reducing the cooling in the core pin.The damaged cannula may occur during the molding process, handling, or use of the device.Without further inspection of the unit it cannot be confirmed with certainty where the defect may have originated.Furthermore, 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.
Event or Problem Description
It was reported that 5 bd threaded lock cannula were damaged, but still operable.The following information was provided by the initial reporter: "the customer reported: some cannulas were found to be short.The customer is requesting for replacement by another lot products.".
Additional Manufacturer Narrative
H.6.Investigation: multiple photos and approximately 531 samples were received.The photos and physical samples represented product from two batches #9340415 and 9340416 (p/n 303369).298 samples were received from batch #9340416 in three 100-count cartons, 228 from batch #9340415 with 198 in two 100-count cartons and 30 in blister packs in a plastic bag.Also 5 unknown loose decontaminated samples were received.The short cannula defect was confirmed in the 5 loose decontaminated samples from cavity 13 and 43.Based on the customer photos there is a short cannula or possible damage to the cannula in five units.Three units in the image on the left below appear to have a short cannula and no signs of damage.Of the two units on the right one unit appears to have a short cannula and the other appears to have a damaged cannula.The short undamaged cannulas are most likely a result of a hot core pin.When the core pin is too hot it may pull the cannula as it is being retracted at the end of the molding cycle and prior to ejection.Additional samples were received for investigation: three hundred two units from lot 9340416, two hundred thirty units from lot 9340415 and five misc.Units.Five hundred thirty-nine samples were received from the customer for investigation.The five unidentified units observed from the customer match the five units covered in the initial investigation.Microscopic examination of the unit with the damaged cannula showed that the tip appears to be melted and folded inward.This indicates that the damage most likely occurred due to an overheated core pin.The unused units were inspected for short or damaged cannulas.Since none of the units were involved in the actual incident, a sample of 76 units were inspected from each batch, if any of those units fail, then all the units will be inspected.None of the unopened units were found to have short or damaged cannula.Investigation conclusions remain unchanged for this revision.During the molding process operators perform visual inspections and maintenance per the sampling plan.A pm (preventative maintenance) is required after 21 days of running the equipment.Each production run is about 7 days.With infrequent runs, pm may end up being as long as 2 years apart.Idle time is likely to allow a build-up in the cooling channel of the core pin, thereby reducing the cooling in the core pin.The damaged cannula may occur during the molding process, handling, or use of the device.
Event or Problem Description
It was reported that 5 bd threaded lock cannula were damaged, but still operable.The following information was provided by the initial reporter: "the customer reported: some cannulas were found to be short.The customer is requesting for replacement by another lot products.".

• Brand Name: BD THREADED LOCK CANNULA
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10469518
• Report Number: 1213809-2020-00582
• Device Sequence Number: 1218108
• Product Code: FMI
• UDI-Device Identifier: 30382903033691
• UDI-Public: 30382903033691
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K011858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/16/2020

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
• Operator of Device: Other
• Device Model Number: 303369
• Device Catalogue Number: 303369
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 08/06/2020; 11/16/2020
• Initial Report FDA Received Date: 08/29/2020
• Supplement Report FDA Received Date: 10/20/2020; 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other