MAUDE Adverse Event Report: BECTON DICKINSON BD SAFE-CLIP; SAFECLIP

Model Number 328235

Device Problems Inaccurate Synchronization (1609); Failure to Cut (2587)

Patient Problem Insufficient Information (4580)

Event Date 08/24/2020

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4) device expiration date: unknown.Device manufacture date: unknown.Investigation summary: level b investigation complaint evaluation / complaint history check for the event(s) that occurred.Severity: s_1__; occurrence: unable to perform complaint lot history check for not clipping and difficult/unable to operate due to unknown lot number.A review of risk management (b)(4) revision 04 indicates that the potential risk of this specific reported incident (safeclip, not clipping, difficult/unable to operate) was captured and addressed investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Unable to perform dhr check for not clipping and difficult/unable to operate due to unknown lot number.Investigation conclusion: as no samples and/or photo(s) were received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: based on the investigation, no additional investigation and no capa is required at this time.

Event Description

It was reported that an unspecified number of bd safe-clips¿ experienced the safeclip not clipping/jammed and device damage while still considered operable.Product defects were noted during use.The following information was provided by the initial reporter: "during a call on (b)(6) 2020, the patient reports that since (b)(6) 2020 the needle cutter has not worked.He states that he is inserting the needle, but at the time of making the cut, the needle cutter slides the needle and does not cut it".

• Brand Name: BD SAFE-CLIP
• Type of Device: SAFECLIP
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10533087
• MDR Text Key: 208798692
• Report Number: 2243072-2020-01420
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 00382903282357
• UDI-Public: 00382903282357
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 328235
• Device Catalogue Number: 328235
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other