MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367001
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.The customer's address is unknown:  (b)(6) usa has been used as a default.  a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0286768.Medical device expiration date: 2002-10-31.Device manufacture date: 2000-10-12.Medical device lot #: 1091217.Medical device expiration date: 2013-04-30.Device manufacture date: 2011-04-01.Medical device lot #: 3241460.Medical device expiration date: 2015-09-30.Device manufacture date: 2013-08-29.Medical device lot #: 5120622.Medical device expiration date: 2017-05-31.Device manufacture date: 2015-04-30.Medical device lot #: 9280864.Medical device expiration date: 2021-10-31.Device manufacture date: 2019-10-07.Medical device lot #: 0227213.Medical device expiration date: 2022-08-31.Device manufacture date: 2020-08-14.
Event or Problem Description
It was reported that 7 bd vacutainers® blood alcohol determinations sodium fluoride experienced erroneous results.The following information was provided by the initial reporter: the bd vacutainer® fluoride tubes outgassed isobutylene that could be mis-identified as methanol when a single-column gas chromatographic system is used.
Event or Problem Description
It was reported that 7 bd vacutainers® blood alcohol determinations sodium fluoride experienced erroneous results.The following information was provided by the initial reporter: the bd vacutainer® fluoride tubes outgassed isobutylene that could be mis-identified as methanol when a single-column gas chromatographic system is used.
Additional Manufacturer Narrative
H6: investigation summary: this complaint was reported in a 2021 paper in the journal of forensic sciences titled "isobutylene contamination of blood collected in 10-ml evacuated blood collection tubes with gray conventional rubber stoppers.Bd had not received samples or photos for evaluation.Therefore, retention samples from bd inventory were visually inspected.100 retentions from lot 0227213 and 9280864 were inspected with no issues were identified.No retentions were available for lots 0286768, 1091217, 3241460, and 5120622.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.Bd has observed the presence of isobutylene in most bd vacutainer® tubes with stoppers using halobutyl rubber.Isobutylene is a monomer used in the production of halobutyl rubber.This complaint is being confirmed based on historical data of a known issue related to rubber stoppers.At this time, no further action is planned, however bd will continue to monitor.H3 other text : see h10.
Additional Manufacturer Narrative
The following field was updated due to additional information: investigation summary: this complaint was reported in a 2021 paper in the journal of forensic sciences titled "isobutylene contamination of blood collected in 10-ml evacuated blood collection tubes with gray conventional rubber stoppers bd had not received samples or photos for evaluation.Therefore, retention samples from bd inventory were visually inspected.100 retentions from lot 0227213 and 9280864 were inspected with no issues were identified.No retentions were available for lots 0286768, 1091217, 3241460, and 5120622.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.Bd reviewed the findings in the article and determined that the issue was previously evaluated in september 2020, through a complaint received by the same customer.In the previous investigation, bd had identified isobutylene in the bd vacutainer® fluoride blood collection tube (material number 367001), which the customer alleged had interfered with methanol analysis.Isobutylene is a raw ingredient in the production of butyl rubber so residual isobutylene is likely to be found in the stoppers.Bd determined that both the previous complaint and findings in the article had used a dual-column gas chromatography system with flame ionization detector, which showed the interference in one of the two columns.Bd also confirmed presence of isobutylene in the chlorobutyl and bromobutyl stoppers used in the product.These complaints highlight the sensitivity of chromatography assays with general detection technologies to outgassed compounds.These methods are laboratory developed tests with each lab choosing columns and instrument conditions to optimize for their method / application making prediction of chromatographic interference infeasible.This is illustrated in the complaints referenced above as only one of the two column analyses in each case was impacted.Additionally, the customers¿ systems worked as intended in identifying an interference through the two-column system.This complaint is being confirmed based on historical data of a known issue related to rubber stoppers.At this time, no further action is planned, however bd will continue to monitor.H3 other text : see h10.
Event or Problem Description
It was reported that 7 bd vacutainers® blood alcohol determinations sodium fluoride experienced erroneous results.The following information was provided by the initial reporter: the bd vacutainer® fluoride tubes outgassed isobutylene that could be mis-identified as methanol when a single-column gas chromatographic system is used.

• Brand Name: BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12866296
• Report Number: 1917413-2021-01007
• Device Sequence Number: 17672134
• Product Code: JKA
• UDI-Device Identifier: 50382903670012
• UDI-Public: 50382903670012
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K901449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2022

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 Model Number: 367001
• Device Catalogue Number: 367001
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2021
• Supplement Date Received by Manufacturer: 03/07/2022; 06/23/2022
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 03/15/2022; 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown