MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL CANADA CHEMO 10.3L RED; SHARPS COLLECTOR

Catalog Number 300162

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/14/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the sharps coll canada chemo 10.3 l red experienced an inability to contain discards biohazard devices.The following information was provided by the customer: material no.300162, batch no.8311002.It was reported the base is cracked.(pharmacy) filled container bd-300162 with water.Container was turned upside down.Leaks.This is a chemotherapy sharp container needs to be hermetic/no leaks.

Manufacturer Narrative

H.6.Investigation: a sample was returned with pictures and forwarded for an investigation.The pictures were evaluated and showed the cap or base was not cracked or defective.The manufacturer also received the bottle in question and physically confirmed no damage to the cap or base.A leak resistance test was performed by placing 1.251 lbs of water in collector (5% of 3 gallons of water) according with product specification for the bottle and found that it did not leak when placed on sides of collector, however when tilting bottles upside down bottles would leak between the cap seat and lid.The requirements for leak resistance state: no leaks when filled with 5% of stated volume and toppled onto side and left for 1 minute.Supplier process method; product specifications; cap seat and lid did not meet specification.At this point a supplier capa will be performed for the possible non-conformance result.H3 other text : see h.10.

Event Description

It was reported that the sharps coll canada chemo 10.3l red experienced an inability to contain discards biohazard devices.The following information was provided by the customer: material no.300162, batch no.8311002.It was reported the base is cracked.(pharmacy) filled container bd-300162 with water.Container was turned upside down.Leaks.This is a chemotherapy sharp container needs to be hermetic/no leaks.

• Brand Name: SHARPS COLL CANADA CHEMO 10.3L RED
• Type of Device: SHARPS COLLECTOR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8465168
• MDR Text Key: 145524034
• Report Number: 2243072-2019-00608
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300162
• Device Lot Number: 8311002
• Initial Date Manufacturer Received: 03/14/2019
• Initial Date FDA Received: 03/29/2019
• Supplement Dates Manufacturer Received: 03/14/2019
• Supplement Dates FDA Received: 08/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other