MAUDE Adverse Event Report: BECTON DICKINSON BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367288

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Needle Stick/Puncture (2462)

Event Date 10/26/2022

Event Type  Injury  

Event Description

It was reported when using the bd vacutainer® safety-lok¿ blood collection set customer have seen approximately 10 needle stick injury from the clinical use of the safety-lok blood collection set.This event occurred 10 times.The following information was provided by the initial reporter.The customer stated: ¿infection prevention and control have advised that over the past 12 months they have seen approximately 10 nsi's from the clinical use of the safety-lok blood collection set.The hospital considers this amount to be significant.They have requested further education and training.There are no samples or batch numbers that they can provide.They use the slbcs in the following codes: 367286, 367288 and 368382.The ipc riskman system does not document guage sizes involved and therefore cannot be tracked.¿.

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is nipro.This site is an oem manufacturing site.(b)(4).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Medical device expiration date: unknown.Device manufacture date: unknown.

Manufacturer Narrative

H,6, investigation summary: bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.This complaint is unable to be confirmed.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.Since the batch number was unknown, our manufacturing and process inspection records of the lots manufactured from january 2021 to the end of june 2022 were reviewed, 152 lots of material # 367288, no abnormalities that could cause malfunction of the safety shields were found.Furthermore, the release inspection records of the lots above were reviewed and no records of abnormalities in the appearance, the breakaway force, sustaining force and security force of the safety shields were found.As it was reported that the needle stick occurred due to the customer not activating the safety shields, it was considered that there was nothing wrong with the product.Moreover, no abnormalities that could lead to malfunction of the safety shields were found from reviewing the manufacturing and inspection records as described above.As stated in the ifu, please hold the end of safety shield and tubing with one hand and slide the safety shield straight to cover the winged needle without holding wings.H3 other text : see h.10.

Event Description

It was reported when using the bd vacutainer® safety-lok¿ blood collection set customer have seen approximately 10 needle stick injury from the clinical use of the safety-lok blood collection set.This event occurred 10 times.The following information was provided by the initial reporter.The customer stated: ¿infection prevention and control have advised that over the past 12 months they have seen approximately 10 nsi's from the clinical use of the safety-lok blood collection set.The hospital considers this amount to be significant.They have requested further education and training.There are no samples or batch numbers that they can provide.They use the slbcs in the following codes: 367286, 367288 and 368382.The ipc riskman system does not document guage sizes involved and therefore cannot be tracked.¿.

• Brand Name: BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15760572
• MDR Text Key: 303330000
• Report Number: 2243072-2022-01917
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367288
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2022
• 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): Required Intervention; Other