MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD DISCARDIT¿ SYRINGE WITH LUER-SLIP TIP 20 ML; SYRINGE WITHOUT NEEDLE

Catalog Number 300296

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Anaphylactic Shock (1703); Anaphylactic Shock (1703); Cardiac Arrest (1762); Cardiac Arrest (1762); Death (1802); Death (1802); Dyspnea (1816); Dyspnea (1816); Necrosis (1971); Necrosis (1971)

Event Date 02/22/2016

Event Type  Injury  

Manufacturer Narrative

Of note, this incident was notified to bd as a medical incident as well as an adverse drug reaction.Results - bhr review: a batch history record for the reported lot number was conducted confirming that the batch was released according to defined procedures and requirements including final testing after sterilization for bis sterility and lal testing.Neither quality notification nor abnormalities were observed during manufacturing.Biological indicator sterility test: biological indicators (bacillus atrophaeus 106 concentration) are used as sterility controls in each sterilization load.Biological indicators sterility test is conducted on each sterilization load as part of the final tests in order to release the product to the market.The bis sterility test was performed on the lot 1512112 with satisfactory results (all bis negative).Lal.Lal test is used to confirm the absence of bacterial endotoxins in the finished product.It's performed using turbidimetric method and it is conducted on each sterile lot as part of the final tests in order to release the product to the market.Lal test was performed on the lot 1512112 with satisfactory results (no presence of bacterial endotoxins).Additional investigation: in addition to the above described tests performed on every batch as part of the final product release, other evaluations are routinely performed to confirm that both product and manufacturing processes met the established microbiological requirements applicable for these medical devices.These manufacturing records have been also reviewed finding all them appropriate with satisfactory results as below: bioburden test: bioburden testing is conducted quarterly by the filtration method and it's also performed as part of the annual sterilization requalification.The purpose of this technique is to determine the number of viable microorganisms on medical devices prior to sterilization.This includes one evaluation for aerobic bacteria, anaerobic bacteria and fungi.Both bioburden test performed prior and after manufacture batch 1512112 (q1"fy"16-q23fy-16) on discardit 20ml syringes were found correct.Cfu average and maximum cfu were below alert and action bioburden limits with satisfactory results.Sterility test with product: sterility test with product is conducted annually during the annual sterilization requalification.The purpose of this technique is to demonstrate that the natural bioburden of the product is eliminated after sterilization.Both sterility test with product performed prior and after manufacture batch 1512112 (march 2015 / march 2016) on two different batches of 20ml discardit syringes were conducted with satisfactory results (no growth in any sample).Environmental monitoring: an environmental monitoring program is defined in the clean room where 20ml discardit syringes are manufactured: clean room i.Every month a viable particle test and non-viable particles test are conducted in the clean room in order to confirm that both are below the alert and action limits.Clean room is classified as iso 9.Tests conducted for viable particles monitoring and non-viable particles monitoring in (b)(4) 2015, when batch 1512112 was manufactured, were satisfactory below the alert and action limits.Clean room annual requalification: an external supplier is annually qualifying the clean room i in order to verify (b)(4) filters and confirm particles clean room classification:.Last clean room requalification was conducted in december 2015, when batch 1512112 was manufactured, with satisfactory results.Biocompatibility, iso 10993 & presence of other substances: preclinical material biocompatibility testing has been conducted on the materials used to manufacture bd discardit syringes and meet established criteria in conformity with the iso 10993, guidelines for the biological evaluation of medical devices and (b)(4) appropriate to the defined use classification.Based on our ongoing data collection efforts and information received from our suppliers, bd has not identified any pvc, latex or bpa in the article referenced above, in individual concentrations above 0,1% weight by weight (w/w).Based on our ongoing data collection efforts and information received from our suppliers, bd has not identified any chemicals in the article referenced above, in individual concentrations above 0,1% weight by weight (w/w), which have been listed as substances of very high concern (svhc) and included in the "candidate list" published by the european chemical agency (echa) on 16 june 2014, according to art.59 (1,10) of the regulation (ec) nº 1907 / 2006 (reach).Conclusion: according to the described circumstances around this incident, the patient experienced the reaction moments after the start of administration of antibiotic.The incident was reported as a medical incident as well as adverse drug reaction, but diagnosis of death was concluded as intestinal necrosis.Considering that all the evaluated manufacturing records and microbiological evaluations were found correct and according to requirements: material biocompatibility confirmed to comply with iso 10993 requirements.Sterility tests with bis and endotoxins (lal) with satisfactory results environmental and process controls confirmed as acceptable to requirements.We conclude that bd discardit syringes should not cause nor contribute to the reported injuries.

Event Description

Of note, this incident was notified to bd as a medical incident as well as an adverse drug reaction.

Manufacturer Narrative

Initial reporter fax # (b)(6).Pma / 510(k)#: this device does not have a 510(k) number.Device manufacture date: 12/2015.

Event Description

It was reported that the patient in the department of gynecology was receiving perioperative antibiotic prophylaxis.Moments after the start of administration, the patient reported dyspnea.Over the next fifteen minutes she developed symptoms of severe anaphylactic shock and cardiac arrest.After an hour of resuscitation, sinus rhythm was achieved.The patient was transferred to the icu.She died on (b)(6) 2016.Diagnosis: intestinal necrosis.No further information is available.

• Brand Name: BD DISCARDIT¿ SYRINGE WITH LUER-SLIP TIP 20 ML
• Type of Device: SYRINGE WITHOUT NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5508301
• MDR Text Key: 42874562
• Report Number: 3002682307-2016-00007
• Device Sequence Number: 0
• Product Code: FMF
• Reporter Country Code: PL
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/07/2016
• 2 Devices were Involved in the Event: 1 2

2 Patient was Involved in the Event

• Date FDA Received: 03/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 300296
• Device Lot Number: 1512112
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2016
• 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: 0
• Patient Outcome(s): Death
• Patient Weight: 63