MAUDE Adverse Event Report: BECTON DICKINSON BD SAFE-CLIP¿ NEEDLE CLIPPER; SHARPS CONTAINER

Catalog Number 328455

Device Problem Failure to Cut (2587)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/10/2021

Event Type  malfunction  

Manufacturer Narrative

Oem manufacture: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that at least 1 bd safe-clip¿ needle clipper was unable to clip.The following information was provided by the initial reporter: facility informed us that he has had problems with the last 3 safe-clips he has gotten from pharmacy.They work ok for a couple of weeks, then the hole where you insert cannula clogs up and it is not possible to insert cannula any more.He has used safe-clip for many years and not experienced this before.He has not changed pen needle kind or brand and not changed anything in his injection therapy.

Event Description

It was reported that at least 1 bd safe-clip¿ needle clipper was unable to clip.The following information was provided by the initial reporter: facility informed us that he has had problems with the last 3 safe-clips he has gotten from pharmacy.They work ok for a couple of weeks, then the hole where you insert cannula clogs up and it is not possible to insert cannula any more.He has used safe-clip for many years and not experienced this before.He has not changed pen needle kind or brand and not changed anything in his injection therapy.

Manufacturer Narrative

H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Unable to perform a dhr review for not clipping (cutter blocked) due to unknown lot number.H3 other text : see h.10.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-10-19.H6: investigation summary customer returned (1) bd safe clip.Customer states that the hole where you insert cannula clogs up and it is not possible to insert cannula any more.The returned safe clip was examined and exhibited several cannula blocking the cutting hole.This can occur during use of the product and this indicates that the sample may now be full and should be replaced.Unable to perform dhr check for not clipping (cutter blocked) due to unknown lot number.H3 other text : see h10.

Event Description

It was reported that at least 1 bd safe-clip¿ needle clipper was unable to clip.The following information was provided by the initial reporter: facility informed us that he has had problems with the last 3 safe-clips he has gotten from pharmacy.They work ok for a couple of weeks, then the hole where you insert cannula clogs up and it is not possible to insert cannula any more.He has used safe-clip for many years and not experienced this before.He has not changed pen needle kind or brand and not changed anything in his injection therapy.

• Brand Name: BD SAFE-CLIP¿ NEEDLE CLIPPER
• Type of Device: SHARPS CONTAINER
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12140642
• MDR Text Key: 260729962
• Report Number: 2243072-2021-01835
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2021

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328455
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2021
• Initial Date FDA Received: 07/09/2021
• Supplement Dates Manufacturer Received: 07/19/2021; 10/19/2021
• Supplement Dates FDA Received: 08/09/2021; 11/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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