MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD SCRUB BRUSH E-Z SCRUB DRY STERILE

Model Number	371603
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that 2 packages were difficult to open prior to use and would rip with a bd scrub brush e-z¿ scrub¿ dry sterile.The following information was provided by the initial reporter: 2 x packets were difficult to open and caused ripping.
Event or Problem Description
It was reported that 2 packages were difficult to open prior to use and would rip with a bd scrub brush e-z¿ scrub¿ dry sterile.The following information was provided by the initial reporter: 2 x packets were difficult to open and caused ripping.
Additional Manufacturer Narrative
Two samples received.Unable to open either sample, although the customer had tried to.Complaint confirmed.The most likely cause would be from the packaging machine stopping, and residual heat from the sealing die locally producing a seal that was too strong.One prior complaint in 2007 dhr reviewed.Seal peel strength is one of the characteristics measure.All measurements were in control limits.H3 other text : see h.10.

• Brand Name: BD SCRUB BRUSH E-Z SCRUB DRY STERILE
• Common Device Name: SCRUB BRUSH
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 10105599
• Report Number: 1710034-2020-00340
• Device Sequence Number: 16682498
• Product Code: GEC
• UDI-Device Identifier: 00382903716036
• UDI-Public: 00382903716036
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: NA
• 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
• Report Date (Section B): 08/03/2020

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 Expiration Date: 06/30/2024
• Device Model Number: 371603
• Device Catalogue Number: 371603
• Device Lot Number: 9184663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Initial Date Received by Manufacturer: 05/11/2020
• Supplement Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 06/01/2020
• Supplement Report FDA Received Date: 08/03/2020
• 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